Recall Z-2427-2021 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips North America LLC
Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator
| Date | Sep 3, 2021 (initiated Jul 16, 2021) |
| Status | Terminated |
| Reason | Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy, or delivery of lower energy than indicated for an adult patient |
| Root cause | Process control |
| Action | On July 26, 2021, Phillips issued an "Urgent Medical Device Removal" notification to affected consignees. On August 23, 2021, Phillips issued a revised "Urgent Medical Device Removal notification to update their recall strategy concerning replacement infant/child smart pads cartridges. In addition to informing consignees about the recalled product, Phillips asked consignees to take the following actions: Action 1: If needed, contact your distributor to request a replacement. Customers who purchased their pads cartridges directly from Philips will receive their replacements without any f |
| Quantity | 19,840 units |
| Distribution | Worldwide distribution. US Nationwide, Australia, Austria, Bolivia, Canada, Chile, China, Denmark, France, French Polynesia, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Republic of Korea, Malta, Martinique, Mexico, Monaco, Netherlands, Norway, Poland, Spain, Switzerland, Taiwan, United Kingdo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.