Recall Z-2549-2019 ยท MKJ Automated External Defibrillators (Non-Wearable)
Philips North America LLC
Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
| Date | Aug 8, 2018 |
| Status | Terminated |
| Reason | The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/child pad cartridges. The infant/child pad cartridge is designed for use with the defibrillator An Infant/Child pad cartridge should not be used on an adult because it delivers lower energy (50 J vs 150 J) than the Adult pads cartridge and may therefore not be effective on an adult. |
| Root cause | Labeling False and Misleading |
| Action | A labeling specification for the HS1 is available against which labeling can be checked prior to design transfer and/or localization. This activity has been moved under regulatory affairs for review and maintenance. |
| Quantity | 181,894 Infant/Child SMART Pads Pads |
| Distribution | US: AK, AL,AR,AZ,CA,CO,CT,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,SD,TN,TX,UT,VA,VT,WA,WI,WV, WY, Argentina, Aruba, Australia, Austria, Belgium, Bolivia, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Denmark, Dominican Re |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020715 | PHILIPS M5066A AND M5068A Philips Medical Systems, Nov 8, 2002 |