HeartStart MRx Processor Board PCA Replacement Kits 453563478461 — Class II medical device recall Z-2064-2020
Terminated recall by Philips North America, LLC, reported 2020-05-27, distributed nationwide. Damaged ESD bags used for storing components in Processor PCA Replacement Kits
| Recall number | Z-2064-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, LLC, Andover, MA, United States |
| Recall initiated | 2020-04-10 |
| Classified | 2020-05-20 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2021-02-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB, NL, ZA |
| Serial numbers | 39IDON1J, C01-1, C01-1639100ND0, C01-16391D0N4N, C01-16391D0N6N, C01-16391D0NB2, CO1-1639100N3T, CO1-1639100N43, CO1-1643IDOTDB |
Product
HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Product Usage: is intended for use in hospital and prehospital settings by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support or defibrillation.
Reason for recall
Damaged ESD bags used for storing components in Processor PCA Replacement Kits
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2064-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.