Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliVue TcG10 is a device for the measurement of th

FDA device recall Z-0997-2015 · posted 2015-01-16 · Terminated

Recall details

Recalling firm

Philips Medical Systems, Inc.

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.

Action taken

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 are involved in the operation of the IntelliVue TcG10 modules and need to be aware of the contents of this communication. The addendum should be stored with the IntelliVue TcG10 Instructions for Use. If you need any further information or support concerning this issue, please contact your local Philips representative or call us at 1-800-722-9377.

Root cause

Under Investigation by firm

Status

Terminated

Product code

LKD

Quantity affected

86

Distribution

Distributed in the states of CA, HI, IL, MA, MI, MO, MT, NC, OH, and PA.

Date initiated

2014-11-19

Date posted

2015-01-16

Date terminated

2015-09-29

Location

Andover, MA

Related 510(k) clearances