Z-1666-2025 Class II Ongoing
FDA device recall Z-1666-2025 was initiated by Remote Diagnostic Technologies Ltd. on April 16, 2025 and is designated Class II. Reason for recall: software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope. The recall status is ongoing. Affected quantity: 6,961 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 30, 2025
- Initiation Date
- April 16, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,961 units
Product Description
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)]
Reason for Recall
software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.
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.
Code Information
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