Home / Recalls / Philips North America LLC / Z-1271-2020

Z-1271-2020 Class II Terminated

Recalled by Philips North America LLC — Bothell, WA

Recall Details

Product Type
Devices
Report Date
February 26, 2020
Initiation Date
September 10, 2019
Termination Date
April 29, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
44 units

Product Description

Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017

Reason for Recall

Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.

Distribution Pattern

HeartStart FRx: US - CA, CT, FL, IL, MO, NY,TN, TX and WI OUS - Australia, Brazil, Canada, Germany, Italy, Japan, South Korea, Norway, Switzerland and Taiwan. HeartStart HS1: US - CT, FL, IL, MI, MS, NJ, TN, TX, WA and WI OUS - Argentina, Australia, Canada, France, Germany, Hong Kong, Italy, Japan, Netherlands, Norway, Spain, Sweden, and Taiwan

Code Information

Model: 861304 Software Version: FRx codeRev: E.02.017 System Serial Numbers: B17G-05063 B17C-03662 B17D-00167 B16G-06056 B16J-03182 B16J-03349 B14J-00603 B15E-08588 B15G-03528 B16A-00186 B16A-00189 B16A-00235 B16J-01934 B17G-02322 B17G-02937 B17I-00135 B18E-01082 B16L-03105 B15L-01146 B14H-00561 B17D-00056 B18E-01975 B16K-02837 B16E-01325 B16E-01627 B15E-06814 B15L-07200 B16K-03381 B13G-04020 B17F-02048 B17I-08789 B14I-00249 B15G-02703 B16E-01403 B16E-00725 B16F-04894 B16J-06377 B16G-05481 B16K-03980 B17F-07414 B17H-05164 B17I-07486 B16C-00187 B17D-00228

Other recalls by Philips North America LLC

  • Z-1952-2026 Class II — Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Num (April 14, 2026)
  • Z-1960-2026 Class II — Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF) (April 14, 2026)
  • Z-1962-2026 Class II — Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): (April 14, 2026)
  • Z-1968-2026 Class II — Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model (April 14, 2026)
  • Z-1956-2026 Class II — Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7813 (April 14, 2026)
  • Z-1955-2026 Class II — Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number ( (April 14, 2026)
  • Z-1957-2026 Class II — Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 7 (April 14, 2026)
  • Z-1964-2026 Class II — Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. (April 14, 2026)
  • Z-1966-2026 Class II — Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model N (April 14, 2026)
  • Z-1953-2026 Class II — Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7812 (April 14, 2026)