Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2) module. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
FDA Recall Z-2347-2015 · Posted 2015-08-06
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Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeDQK
Date Initiated2015-01-21
Date Terminated2015-12-09
Product Quantity451
Reason for Recall
A system freeze-up of the Merge Hemo system, that included the PHASEIN End Tidal CO2 unit, resulted in the user needing to move the patient to another cath lab.
Firm Action
Merge Healthcare sent an Important Product Information letter dated January 21, 2015, to all affected consignees. The letter described the Issue, Affected Product, Instructions, Product Updates, and Contact Information. For questions contact Merge Customer Service at (877) 741-5369 or [email protected]
A second UPDATE letter was sent April 16, 2015. The letter included the Product Updates.
For questions regarding this recall call 866-261-5761.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution including IL, SC, WI, AL, CT, CA, LA, NM, TX, OK, GA, IA, OH, FL, CO, TN, NY, NC, MA, AR, MO, HI, ND, AK, UT, WV, WA, AZ, MI, PA, ME.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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