Philips IntelliVue TcG10 — Class II medical device recall Z-0997-2015
Terminated recall by Philips Medical Systems, Inc., reported 2015-01-28, distributed in CA, HI, IL, MA, MI, MO, MT, NC…. Philips has discovered that the Instructions for Use (IFU) for the IntelliVue TcG10 Transcutaneous Gas Measure
| Recall number | Z-0997-2015 |
|---|---|
| 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 | 2014-11-19 |
| Classified | 2015-01-16 |
| Reported by FDA | 2015-01-28 |
| Terminated | 2015-09-29 |
| Distributed | CA, HI, IL, MA, MI, MO, MT, NC, OH, PA |
| Quantity | 86 |
| Serial numbers | CH03800507, CH03800508, CH03800509, CH03800510, CH03800559, CH03800560, CH03800573, CH03800574, CH03800575, CH03800576, CH03800577, CH03800578, CH03800579, CH03800580, CH03800633, CH03800634, CH03800637, CH03800638, CH03800642, CH03800676, CH03800678, CH03800685, CH03800687, CH03800688, CH03800690 and 61 more |
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.
Reason for recall
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.
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-0997-2015. 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.