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 | Philips has discovered that the Instructions for Use (IFU) for the IntelliVue TcG10 Transcutaneous Gas Measurement Module is missing the contraindication that the device is not to be used on patients under gas anesthesia. |
| Product | Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliVue TcG10 is a device for the measurement of the transcutaneous O2 and CO2 partial pressure in neonates, pediatrics and adults. |
| Quantity | 86 |
| Distribution | Distributed in the states of CA, HI, IL, MA, MI, MO, MT, NC, OH, and PA. |
| Initiated | 2014-11-19 |
| Classified | 2015-01-16 |
| Terminated | 2015-09-29 |
| Recall number | Z-0997-2015 |
| 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-0997-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69742/
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