Merge Healthcare, Inc.: Merge PACS

Is my product affected?

Merge PACS

• UPC 00842000100805

Check against the official notice below — it lists the full affected range.

What happened

Merge Healthcare, Inc. is recalling 125 units of Merge PACS, a medical imaging system, because measurements taken on multiplanar reconstructions (MPRs) generated by the device may be incorrect. The affected devices were distributed domestically across 24 states including Illinois, Missouri, New York, Florida, California, and others, as well as internationally in Canada, Belgium, and the United Kingdom. The recall involves multiple software versions identified by specific UDI codes and lot numbers ranging from October 2019 through July 2020.

The recall notice does not specify a remedy or recommended action for affected consumers or healthcare facilities.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Measurements done on the Merge PACS generated MPR s may have incorrect measurements. Distribution: 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. Quantity: 125 total units Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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