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Open, Classified

Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]

FDA Recall Z-1666-2025 · Posted 2025-04-24

Recalling FirmRemote Diagnostic Technologies Ltd.
Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2025-04-16
Product Quantity6,961 units

Reason for Recall

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

Firm Action

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

Distribution Pattern

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, TN, TX, UT, VA, WA, WI, WV, WY and the countries of AE, AF, AT, AU, BE, BO, CA, CH, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IL, IS, IT, KY, MY, NL, NO, OM, PL, PT, RO, SA, SE, SG, SI, SL, TH, ZA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited · 2020-09-18K130773TEMPUS PRO PATIENT MONITORRemote Diagnostic Technologies , Ltd. · 2013-06-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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