Philips V60 Ventilators with Power Management PCBA part number 1055906
FDA Device Recall #Z-1622-2020 — Class II — March 5, 2020
Recall Summary
| Recall Number | Z-1622-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 5, 2020 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Respironics California, LLC |
| Location | Carlsbad, CA |
| Product Type | Devices |
| Quantity | 23581 |
Product Description
Philips V60 Ventilators with Power Management PCBA part number 1055906
Reason for Recall
Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual and audible High Priority Check Vent alarm indicating a need for alternative ventilation, or 2) Intermittent connection may disrupt expected operation and trigger unexpected shutdown without alarm. Failures may lead to hypercarbia/hypoxemia
Distribution Pattern
U.S.: CO, PA, AZ, OH, MT, AR, FL, NC, KS, IL, CA, HI, MD, SC, WY, OR, NY, NE, OK, MN, UT, ND, LA, IN, AL, AK, WV, GA, WI, MI, VA, NJ, TX, WA, SD, KY, TN, MS, MO, DE, MA, VT, CT, IA, NV, ID, ME, NM, DC, NH, VI, RI, PR. O.U.S.: Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Gibraltar, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jersey, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Maldives, Malta, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam
Lot / Code Information
Serial Numbers: 100002908 to 100027093; 100027096 to 100085389; 100085399 to 100109746; 100109868 to 201003390; 201003392 to 201010952
Other Recalls from Respironics California, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0909-2022 | Class I | Philips Respironics V680 Ventilator (All Models... | Feb 28, 2022 |
| Z-0908-2022 | Class I | Philips Respironics V60 Plus Ventilator (All Mo... | Feb 28, 2022 |
| Z-0907-2022 | Class I | Philips Respironics V60 Ventilator (All Models,... | Feb 28, 2022 |
| Z-0662-2022 | Class I | Philips Respironics V60 Ventilator Part Number ... | Jan 24, 2022 |
| Z-0663-2022 | Class I | Philips Respironics V60 Plus Ventilator Part Nu... | Jan 24, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.