Home / Recalls / Philips North America LLC / Z-2427-2021

Z-2427-2021 Class II Terminated

Recalled by Philips North America LLC — Bothell, WA

Recall Details

Product Type
Devices
Report Date
September 15, 2021
Initiation Date
July 16, 2021
Termination Date
May 12, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19,840 units

Product Description

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

Reason for Recall

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

Distribution Pattern

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 Kingdom, and Uruguay

Code Information

Lot Y111220-01

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  • Z-1316-2026 Class II — IQon Spectral CT; Product Code (REF): 728332; (January 7, 2026)
  • Z-1156-2026 Class II — Patient Information Center iX; Software Version Number: 4.5.0 (December 22, 2025)
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  • Z-1208-2026 Class II — Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11. (December 3, 2025)
  • Z-1207-2026 Class II — Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW (December 3, 2025)