Philips HeartStart XL+ Defibrillator/Monitor with system software… — Class II medical device recall Z-1438-2014
Terminated recall by Philips Medical Systems, Inc., reported 2014-04-16, distributed nationwide. Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possi
| Recall number | Z-1438-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2014-04-02 |
| Classified | 2014-04-09 |
| Reported by FDA | 2014-04-16 |
| Terminated | 2020-09-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, CA, CH, CN, CZ, DE, DK, ES, FR, GB, IT, KR, LV, NL, NO, NZ, PH, PT, TH, TR |
| Quantity | 9,872 units |
| Reason classes | software |
| Model numbers | 861290 |
Product
Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator.
Reason for recall
Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay in therapy.
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-1438-2014. 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.