Recall Z-0881-2022 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips North America LLC
Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
| Date | Apr 6, 2022 (initiated Feb 4, 2022) |
| Status | Open, Classified |
| Reason | There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad. |
| Root cause | Under Investigation by firm |
| Action | On March 4, 2022, Philips mailed an Urgent Medical Device Correction notification. On December 14, 2022, Philips issued an Urgent Medical Device Correction - Expansion notification, dated November 15, 2022. The recall was expanded to notify customers who received an HS1/OnSite/Home AED more than 10 years ago. 1. Keep your HS1/OnSite/Home AED in service until you receive updated pads. If you need to use your HS1/OnSite/Home AED before receiving updated pads cartridge, ensure the majority of the pad surface is covered with gel and apply the pads to the patient. If the gel begins to separate |
| Quantity | 1,696,047 |
| Distribution | Worldwide distribution. US Nationwide including Puerto Rico and Guam, Germany, Australia, Sweden, Japan, Canada, Taiwan, France, Netherlands, Spain, Singapore, Austria, South Africa, Italy, United Kingdom, India, Malaysia, Switzerland, Chile, Ireland, Norway, Hong Kong, Argentina, Mexico, Bolivia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.