FDA Medical Device Recalls (openFDA)
Remote Diagnostic Technologies Ltd.: 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)]
- Recall number
- Z-1666-2025
- Recalling firm
- Remote Diagnostic Technologies Ltd.
- Product
- 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)]
- Status
- Open, Classified
- Initiated
- 2025-04-16
- Posted
- 2025-04-24
- Terminated
- not on file
- Reason
- software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.
- Root cause
- Device Design
- 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.
- Quantity
- 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, 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.
- Lot, serial or model codes
- All Lots/ UDI-DI(s): 00-1004-R - 05060472440020 & 05060472442901; 00-1007-R - 05060472440013 & 05060472442918; 00-1024-R - 05060472441027 & 05060472442925; 00-1026-R - 05060472441058 & 05060472442932; 00-1004 - 05060472440624; 00-1007 - 05060472440655
- 510(k) numbers
- ["K130773","K201746"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 3003832357
- Firm city
- Farnborough
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28