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Terminated

Merge PACS

FDA Recall Z-2944-2020 · Posted None

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2020-08-06
Date Terminated2022-11-30
Product Quantity125 total units

Reason for Recall

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

Firm Action

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.

Root Cause

Software design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K192455Merge PACSMerge Healthcare Incorporated · 2019-10-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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