Device product

Merge PACS

Z-2944-2020

August 06, 2020

Class II

Product summary

Firm: Merge Healthcare, Inc.
Event: Event 86205
Status: Terminated
Classification: Class II
Quantity: 125 total units
Official record key: device-enforcement:Z-2944-2020

Official wording

Reason: Measurements done on the Merge PACS generated MPR s may have incorrect measurements.

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

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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Measurements done on the Merge PACS generated MPR s may have incorrect measurements.