Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF 01-2044 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Full screen error message may occur on patient monitors with affected hardware version, either during or after laryngoscopes are unplugged from monitors, informing users a 60-100 second shutdown/restart are required. Error prevents: viewing graphical patient vital signs, sounding of pulse audio tone, visualization of patient airway used during intubation; may lead to treatment delay or hypoxia.

Recommended Action

Per FDA guidance

On 8/24/23 Correction Notices were mailed to customers and distributors who were asked to do the following: 1) If monitor has Trizeps-7 Hardware, remove the laryngoscope from service with this monitor. Users must use an alternative laryngoscope not connected to the Tempus Pro Monitor to manage the patient s airway to avoid interruption in patient care. The Tempus Pro Monitor can remain in service if the Tempus Pro Video Laryngoscope is not connected to the monitor. 2) If monitor has Trizeps-6 Hardware, the laryngoscope can continue to be used with the monitor. 3) Post this Urgent Medical Device Correction letter on or near the affected device. 4) Pass this notice on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred (if appropriate). 5) Complete and return the Urgent Medical Device Correction response form. Distributors were asked to take the following additional actions: If you have any Tempus Pro Video Laryngoscopes or any Tempus Pro Monitors in stock that have not been distributed, do not distribute them. Modify the response form to include your firm's contact information and then send the response form along with the customer correction notice to customers. If you need any further information or support contact the firm at (800) 722-9377 or email RDT.RecalI.Response@Philips.com. On 11/6/23, updated correction notices were distributed adding two additional models that could become affected if their hardware is updated. Additionally, the notices asked customers to install software (V07.34) on Tempus Pro Monitors according to installation instructions.

Distribution

As reported by FDA

AL, AZ, CA, CO, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, TN, TX, UT, VA, WA, WV, WI, WY, DC