Recall Z-0997-2015 ยท LKD Monitor, Carbon-Dioxide, Cutaneous
Philips Medical Systems, Inc.
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.
| Date | Jan 16, 2015 (initiated Nov 19, 2014) |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Customers were notified of the recall by letter sent via UPS on November 19, 2014. The Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Philips asked customers to do the following: Upon receipt of this notification, ensure that the IntelliVue TcG10 addendum to the Instructions for Use is being reviewed and implemented by all members of your staff who operate the device. Review this information with all staff members who |
| Quantity | 86 |
| Distribution | Distributed in the states of CA, HI, IL, MA, MI, MO, MT, NC, OH, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110474 | PHILIPS INTELLIVUE TCG10 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, Sep 30, 2011 |