Z-2944-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 16, 2020
- Initiation Date
- August 6, 2020
- Termination Date
- November 30, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 125 total units
Product Description
Merge PACS
Reason for Recall
Measurements done on the Merge PACS generated MPR s may have incorrect measurements.
Distribution Pattern
Domestic Distribution: IL, MO, NY, ND, MI, TX, FL, OH, UT, NE, MS, MN, DE, AR, CA, WI, MD, NC, NH, GA, VA, SC, PE, CT, NM, IN. International Distribution: CA, BE, UK.
Code Information
Unique Device Identifier (UDI): v8.1: PACS:(01)00842000100805(10)8.1(11)191022 OrthoPACS: (01)00842000100805(10)8.1(11)191022 v81.1: PACS: (01)00842000100805(10)8.1.1(11)200528 OrthoPACS: (01)00842000100805(10)8.1.1(11)200528 V8.1.2 PACS: (01)00842000100805(10)8.1.2(11)200709