Z-2944-2020Class II

Merge PACS

Name: Z-2944-2020 Merge PACS
Creator: Merge Healthcare, Inc.
Published: 2020-08-06
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2020-08-06 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge PACS on 2020-08-06. FDA classified it as Class II and gives the reason as "Measurements done on the Merge PACS generated MPR s may have incorrect measurements". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2944-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-06
Posted: 2020-09-09
Terminated: 2022-11-30
Recalling firm: Merge Healthcare Incorporated
Product: Merge PACS
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Measurements done on the Merge PACS generated MPR s may have incorrect measurements.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 125 total units
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2944-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2944-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-16	2020-09-09

Product code LLZ

K192455Class IIMerge PACSMerge Healthcare Incorporated / cleared 2019-10-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)