Merge Healthcare, Inc.: 38 recalls on record

Recalls filed with 1 agency: FDA (38).

First recall on record: October 22, 2014. Most recent: September 2, 2026.

Risk classification: Class II: 38

Most recent recalls

DateAgencyProduct
September 2, 2026FDAMerge PACS and Merge OrthoPACS, medical imaging diagnostic workstationZ-3004-2026
August 12, 2026FDAMerge PACS, medical imaging diagnostic workstationZ-2874-2026
August 12, 2026FDAMerge OrthoPACS, medical imaging diagnostic workstationZ-2875-2026
March 26, 2025FDAVERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0…Z-1398-2025
March 26, 2025FDAVERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1…Z-1399-2025
July 31, 2019FDAMerge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1Z-2063-2019
August 8, 2018FDAMerge Unity software, formerly known as DR Systems Unity PACS software. The firm name on…Z-2566-2018
September 13, 2017FDAMerge Unity software, formerly known as DR Systems Unity PACS software. The firm name on…Z-3105-2017
July 26, 2017FDAMerge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the displa…Z-2754-2017
July 19, 2017FDAThe Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major compone…Z-2707-2017
July 5, 2017FDAMasimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage:…Z-2641-2017
July 5, 2017FDASpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Produ…Z-2640-2017
June 28, 2017FDAMerge OrthoPACS software.Z-2620-2017
June 21, 2017FDAMerge PACS software. Merge PACS (Picture Archiving Communication System) is designed an…Z-2591-2017
May 31, 2017FDAMerge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. …Z-2123-2017
May 10, 2017FDASchiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The Pha…Z-1923-2017
April 19, 2017FDAiConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Heal…Z-1762-2017
April 19, 2017FDAMerge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. M…Z-1778-2017
April 5, 2017FDAMerge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge E…Z-1681-2017
March 29, 2017FDAMerge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthca…Z-1498-2017
March 29, 2017FDAMerge Cardio software. Product Usage: Merge Cardio is a system intended to be used …Z-1517-2017
March 29, 2017FDAMerge Cardio software.Z-1486-2017
March 29, 2017FDAMerge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Har…Z-1415-2017
March 29, 2017FDAMerge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Me…Z-1496-2017
March 15, 2017FDAMerge PACS software. The firm name on the label is Merge Healthcare.Z-1431-2017

Questions about this company

How many recalls does Merge Healthcare, Inc. have?
Recalert has 38 U.S. recalls on record for Merge Healthcare, Inc., published between October 22, 2014 and September 2, 2026.
What was the most recent Merge Healthcare, Inc. recall?
FDA recall Z-3004-2026, published September 2, 2026: Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Which agencies have handled Merge Healthcare, Inc. recalls?
Merge Healthcare, Inc. appears as the recalling firm in recalls from: FDA (38).

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