Class II — Philips Medical Systems, Inc.
| Recalling firm | Philips Medical Systems International BV |
|---|---|
| Registered facility | View this company's 54 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Software communication failure may occur on the HeartStart XL+ locking the user out of clinical mode and possibly causing a delay in therapy. |
| Product | Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator. |
| Quantity | 9872 units |
| Distribution | Worldwide Distribution - USA (nationwide) including the countries of: ARGENTINA AUSTRALIA AUSTRIA BELGIUM CANADA CHINA CZECH REPUBLIC DENMARK FRANCE GERMANY ITALY LATVIA NETHERLANDS NEW ZEALAND NORWAY PHILIPPINES PORTUGAL SOUTH KOREA SPAIN SWITZERLAND THAILAND TURKEY and UNITED KINGDOM. |
| Initiated | 2014-04-02 |
| Classified | 2014-04-09 |
| Terminated | 2020-09-16 |
| Recall number | Z-1438-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Philips Medical Systems, Inc. (Z-1438-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67862/
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