The most critical component in your medical device may not be the high-tech sensor or the advanced processor, but the seemingly simple printed circuit board assembly (PCBA) that costs less than a coffee.
In the medical device manufacturing sector, a troubling trend has emerged: since 2024, recall events triggered by PCBA issues have significantly increased. From dialysis machines to ventilators, defibrillators to balloon pumps—devices that mean the difference between life and death are frequently facing recall due to defects in PCBA components worth merely $5-10.
As the “central nervous system” of medical devices, PCBA quality directly determines device reliability and safety. While Tortai Technologies may not currently operate a 100,000-class cleanroom, we ensure high-reliability medical PCBA through stringent environmental control systems and comprehensive quality management processes.
The $5 PCBA: Why It Has Become a Hotspot for Medical Device Recalls
In medical devices, PCBA typically accounts for less than 5% of the total machine cost but contributes to over 30% of failure rates. Behind this disproportionate risk lies the medical device industry’s exceptionally demanding requirements for PCBA reliability, far exceeding those for consumer electronics.
The fundamental difference between medical devices and ordinary electronic products is that any failure in the former may directly endanger patient lives. The Medtronic Newport ventilator recall serves as a prime example: two capacitors on the ventilator’s controller PCBA, worth just a few dollars each, carried abnormal failure risks that could cause the device to suddenly shut down, resulting in 1 death and 2 serious injuries.
PCBA issues are particularly challenging due to their (hidden nature). Much like metabolic disorders showing minimal initial symptoms, process defects in PCBA may be difficult to detect during factory testing but gradually manifest during clinical use. At Tortai Technologies, when analyzing customer cases, we found that one industrial control board had a return rate as high as 2.6%, with 70% of problems traced to preventable process issues such as solder voids and reversed components.
Three Medical PCBA Failure Cases Revealing the Real Causes Behind Recalls
Case 1: Respiration Ventilator PCBA Capacitor Failure Leading to Patient Death
A well-known brand recalled specific batches of its Newport HT70 and HT70 Plus ventilators, with the FDA classifying it as a Class I recall—the highest risk level. The root cause was two capacitors on the ventilator’s controller PCBA posing abnormal failure risks.
Although the probability of both capacitors failing simultaneously in the same device is extremely low, the failure of either could lead to sudden shutdown during operation or failure of the alarm system. To date, the company has received 63 related reports, including 2 serious injuries and 1 death.
This case highlights a critical requirement for medical device PCBA: the failure of a single component should not lead to system malfunction. Redundant design and fault-safe mechanisms are core requirements distinguishing medical PCBA from ordinary circuit boards.
Case 2: Defibrillator PCBA Solder Defects Causing Failure of Defibrillation Function
Another company’s LIFEPAK 12 defibrillator/monitor was classified by the FDA as a Class II recall due to soldering defects on the PCBA. The affected devices’ bidirectional printed circuit boards had soldering defects at the H-bridge component, preventing the devices from delivering electroshock defibrillation.
During cardiac arrest emergencies, such defects could delay treatment or prevent defibrillation entirely, potentially leading to preventable deaths. Although the recall level was lower than the ventilator case, the potential risk was equally critical.
This case underscores the importance of soldering processes in medical PCBA manufacturing. Seemingly minor soldering defects can become a “fatal blow” at critical moments.
Case 3: Balloon Pump PCBA Communication Failure Causing Unexpected Shutdown
A balloon pump giant was recalled 9 times within one year, with one FDA Class I recall primarily due to “communication loss between the executive processor PCBA and the video generator PCBA potentially leading to unexpected shutdown”.
Such shutdowns would occur without warning or alarm alerts. Unexpected pump shutdown and treatment interruption could lead to hemodynamic instability, organ damage, or even death, particularly for critically ill patients. The company reported 42 complaints about PCBA communication failures causing unexpected shutdowns.
This case illustrates the importance of collaborative reliability between PCBA systems within medical devices. Even if individual PCBAs are defect-free, communication failures between them can lead to system-level failures.
Deep-Rooted Causes of PCBA Defects Extend Beyond Components Themselves
Process Parameter Deviations: Similar to “Metabolic Disorders”
Similar to insulin deficiency in hyperglycemia patients, imbalances in PCBA manufacturing process parameters can lead to severe consequences. Tortai Technologies once assisted a medical device client in analyzing batch PCBA board yellowing issues, discovering phenomena akin to “oxidative stress responses”: flux residues not thoroughly cleaned, carbonizing under reflow high temperatures.
Further investigation revealed that during wave soldering using foam/spray methods, nozzle deviation and poor atomization caused uneven coating. Combined with improper reflow temperature profile settings—poor control of temperature rise rate during preheating and overly short dwell time—led to incomplete flux reaction and carbonization/yellowing in high-temperature zones.
Management System Deficiencies: Resembling “Systemic Pathologies”
PCBA quality issues rarely stem from a single factor but rather problems within the entire management system. An automotive component supplier once faced a soldering defect rate as high as 1.5%. The quality team, through 5-Why analysis, discovered that the problematic solder joints appeared normal but had incomplete solder nugget formation.
In-depth analysis revealed: unstable welding current due to severe electrode wear, which resulted from unreasonable maintenance cycles. Furthermore, Equipment Maintenance cycles for Shift B were significantly longer than for Shift A, with lax maintenance quality checks. New model side panels used new materials, yet welding parameters followed old model standards without sufficient validation.
This case reveals systemic deficiencies in quality management systems, akin to multiple organ dysfunction in hyperglycemia patients.
Insufficient Environmental Control: Potential Risks
Although Tortai Technologies doesn’t have a full 100,000-class cleanroom, we ensure medical PCBA manufacturing requirements are met through strict environmental control measures in key areas:
Localized clean work areas: Set up clean benches at critical process points, achieving ISO Class 7 equivalent cleanliness；
Precise temperature and humidity control: Maintain environment at 22±2°C, 45±5% RH；
Rigorous electrostatic protection: Work surface resistance controlled at 10^6-10^9Ω, employees equipped with anti-static gear.
We implement strict personnel access management systems, including wearing anti-static clothing and wrist straps, and restricting unnecessary personnel entry into production areas. All employees receive regular clean operation training to ensure every (link) meets medical PCBA production requirements.
Tortai Technologies Multi-Layered Protection Strategy to Avoid Recall Risks at the Source
Pre-Manufacturing Design for Manufacturability (DFM) Analysis
Before initiating each medical device project,Tortai Technologies conducts comprehensive DFM analysis. Our engineering team evaluates the design’s manufacturability, identifies potential process risks, and provides optimization suggestions.
For instance, addressing common high-density PCB challenges in medical devices, we employ stencil multi-step designs to compensate for height differences, simultaneously adjusting squeegee pressure and printing speed, and adding 3D SPI to detect bump height. This proactive intervention strategy can prevent 80% of manufacturing issues.
Regarding cleaning processes, we consider cleanliness requirements at the design stage: ensuring sufficient clearance under bottom-terminated components like BGA and QFN; avoiding excessively small gaps between high-density pads to ensure cleaning agent penetration; and distributing vias and pads evenly to prevent liquid retention.
Full-Process Control and Data Traceability
We’ve introduced real-time monitoring systems that automatically adjust key process parameters, triggering immediate alarms and stoppages if fluctuations exceed control limits. This “error-proof” design ensures timely problem identification and correction.
For specific requirements of medical PCBA, we’ve established a comprehensive standard system for process parameters. Taking reflow soldering as an example, we strictly control preheat time (90-120 seconds) and peak temperature (245-250°C) to ensure solder joint quality meets medical-grade requirements.
Regarding cleanliness control, we use low-residue or no-clean fluxes, controlling reflow temperature profiles to prevent flux charring and carbonization. For critical circuits or high-speed signal lines, we prioritize selecting washable materials and arrange appropriate cleaning processes.
Comprehensive Inspection Systems and Failure Analysis Capabilities
Tortai Technologieshas established a multi-dimensional inspection system covering every step from raw materials to finished products:
| Inspection Stages | Testing Method | Acceptance Criteria | Medical-Grade Requirements |
| Solder Paste Printing | D SPI | Thickness Deviation ≤10% | High-Precision Measurement |
| Component Placement | 2D/3D AOI | Misalignment ≤0.025mm | Miniature Component Inspection |
| Solder Quality | X-Ray | Voiding Ratio <25% | BGA 100% Inspection |
| Cleanliness Test | Ionic Contamination Test | ≤1.56ug/c㎡ | Compliance with Medical Standards |
For medical PCBA, we particularly enhance cleanliness testing, using ROSE testers to measure ionic contamination levels, ensuring control below 1.56μg/cm² NaCl equivalent. Simultaneously, we conduct particulate testing to ensure the number of particles ≥5μm complies with medical standards.
For abnormal situations, we employ techniques like cross-section analysis + SEM/EDS component analysis for root cause analysis to prevent recurrence.
Conclusion
In the medical device field, reliability isn’t an expense—it’s an investment. A $5 PCBA can determine the fate of a device worth hundreds of thousands of dollars, and more importantly, patient safety.
Through systematic quality control approaches, we elevate medical PCBA reliability to industry-leading levels. Even without a 100,000-class cleanroom, we ensure high-reliability medical PCBA through strict zoning control, process optimization, and company-wide quality awareness. One of our automotive electronics clients, through systematic improvements, reduced their soldering defect rate from 1.5% to below 0.3%, saving over ¥18 million in direct costs. This rigorous process control philosophy is equally applied to medical PCBA manufacturing.
When selecting PCBA suppliers, medical device companies should look beyond surface facilities and focus on their quality systems, process control capabilities, and industry experience. Only by establishing strategic partnerships based on mutual trust can we avoid recall risks at the source and collectively safeguard patient safety.