Reported Dec 14, 2016 · Terminated

Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy…

Merge Healthcare, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Merge Healthcare, Inc. · 900 Walnut Ridge Dr · Hartland, WI · 53029-8347

Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.

Lot codes and dates: Versions V6 GA
6.0 MR1
V6 MR1 CU1
V6 MR1 CU1 SF1
V6 MR1 CU4
V6 MR1 CU5
V6 MR1 CU6
V6 MR1 CU7
V6 MR1 CU8
6.0 MR2
6.0 MR3
6.0 MR3 CU
6.0 MR4
6.0 MR4 CU1
6.0 MR4 CU2
6.0 MR4 CU3
6.0 MR4 CU4
6.0 MR4 CU5
6.0 MR4 CU6
6.0 MR4
CU7
6.0 MR4 CU8
6.0 MR4 CU9
6.0 MR4 CU10
6.0 MR4 CU11
6.1
6.1.1
6.1.2
6.1.3
6.2
6.2.1
6.2.2
6.2.3
6.2.4
6.2.5
6.3
6.4
6.4.1
6.4.2
6.4.3
6.4.4
6.4.5
6.4.6
6.4.7
6.5
6.5.5
6.5.6
6.5.7
6.5.8
6.5.9
6.6
6.6.1
6.6.1.1
6.6.2
6.6.2.1
6.6.2.2
7.0
7.0.1
and 7.0.2
Amount recalled: 537 sites potentially have the affected versions

The agency filed one notice per product. You are reading one of them; the other one is below.

Cut lines on the image may present horizontally rather than vertically.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.

54 in total.