Z-1729-2025 Class II Ongoing
FDA device recall Z-1729-2025 was initiated by Remote Diagnostic Technologies Ltd. on April 15, 2025 and is designated Class II. Reason for recall: Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or … The recall status is ongoing. Affected quantity: 6961.
Recall Details
- Product Type
- Devices
- Report Date
- May 14, 2025
- Initiation Date
- April 15, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6961
Product Description
Reason for Recall
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of AZ, VA, FL, CA, TX, NM, IA, NJ, TN, OH, KS, IN, NC, IL, WY, WI, NV, NY, NE, PA, AL, , MA, GA, MO, CO, OK, KY, OR, MS, MI, HI, WA, UT, WV, ID, ND, NH, MN, MT, ME, MD, DE, DC and the countries of AU, GB, IT, SA, DE, AE, BO, FR, ES, BE, IL, SG, CA, IE, TH, NL, MY, AT, DK, RO, CH, IS, PT, NO, HK, PL, KY, OM, CZ, SI, SL, ZA, AF, SE, FI.