Merge PACS recallZ-2944-2020 · Merge Healthcare, Inc. · initiated Aug 6, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Merge Healthcare, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Measurements done on the Merge PACS generated MPR s may have incorrect measurements.
FDA root cause category: Software design
What the company is doing
The firm, IBM Watson Health, sent an "Urgent Field Safety Notice" dated 05 August 2020 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to do the following: Avoid incorrect pixel measurements by using the following workflow: Step 1: Modality acquires a series and generates reformat and sends to Merge PACS Step 2: Radiologist performs measurement on these series from the modality. Avoid black dots that may lead to additional imaging by taking any of the following actions: - Verifying study images either at modality or in another viewer. - Increasing the window level will window out the lowest pixel value (the black dots). - Viewing additional images/series within the study. Viewing of prior series/studies. - Verifying patients history, diagnosis or other clinical data. IBM Watson Health/Merge Healthcare will provide a software correction to address these issues. A representative will be in contact with you to schedule the software update. Please ensure all potential users of Merge PACS v8.1, 8.1.1 and 8.1.2 have received this notice. Please provide this notice to other organizations impacted by this action. If you have any questions regarding this notice, please contact Customer Support at [email protected] or 877-741-5369.
Recall details
- Recall number
- Z-2944-2020
- Status
- Terminated
- Initiated by the company
- Aug 6, 2020
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 125 total units
- Product code
- LLZ
- FDA submissions
- K192455
- 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.
Product description
Merge PACS
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Merge PACS 8.1Merge Healthcare Solutions Inc. · System, Image Processing, Radiological1 recall3 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K192455 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Merge PACS 9.5Merge Healthcare Solutions Inc. · System, Image Processing, Radiological1 recall1 report
- Merge PACS 9.4Merge Healthcare Solutions Inc. · System, Image Processing, Radiological1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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