# FDA recall Z-2549-2019

> **Philips North America LLC** · Class II · device recall initiated 2018-08-08.

## Product

Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758

## Reason for recall

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.

## 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 Republic,  Egypt,  El Salvador,  France,  French Guiana,  Germany,  Greece,  Guadeloupe,  Hong Kong,  India,  Indonesia,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Malta,  Martinique,  Mauritius,  Mexico,  Netherlands,  Netherlands Antilles,  New Caledonia,  New Zealand,  Norway,  Panama,  Paraguay,  Peru,  Philippines,  Poland,  Puerto Rico,  R¿union,  Singapore,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Trinidad and Tobago,  United Arab Emirates,  United Kingdom,  Uruguay,  Viet Nam,

## Key facts

- **Recall number:** Z-2549-2019
- **Recalling firm:** Philips North America LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-08
- **Report date:** 2019-10-02
- **Termination date:** 2021-04-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bothell, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2549-2019

## Citation

> AI Analytics. FDA recall Z-2549-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2549-2019. Source: US FDA. Licensed CC0.

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