Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (

FDA device recall Z-1666-2025 · posted 2025-04-24 · Open, Classified

Recall details

Recalling firm

Remote Diagnostic Technologies Ltd.

Reason for recall

software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.

Action taken

On April 16, 2025, Remote Diagnostic Technologies Ltd (subsidiary of Philips) issued a Urgent Medical Device Correction to affected consignees via mail. Philips ask consignees to take the following: 1. DO NOT connect the Video Laryngoscope USB probe to the Tempus Pro during device boot-up. Once Patient Details dialog appears, enter patient data, then plug in the Video Laryngoscope USB probe. 2. If the Tempus Pro Monitor displays the error dialog screen (where the user is asked to restart the device), press the Shutdown Button and restart the Tempus Pro Monitor. 3. Keep a copy of this letter with or near your Tempus Pro Monitor. 4. Complete and return the Urgent Field Safety Notification Response Form included with this letter within 30 days of receipt of this notice. 5. This notice must be shared with all relevant personnel within your organization and with any organization where the potentially affected devices have been transferred.

Root cause

Device Design

Status

Open, Classified

Product code

MHX

Quantity affected

6,961 units

Distribution

Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA

Date initiated

2025-04-16

Date posted

2025-04-24

Location

Farnborough, United Kingdom

Related 510(k) clearances