McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical
FDA device recall Z-0042-2015 · posted 2014-10-08 · Terminated
Recall details
- Recalling firm
- Mckesson Information Solutions LLC
- Reason for recall
- Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations.
- Action taken
- On August 27, 2014, McKesson initiated a correction via a Field Safety Notice to all affected domestic customers. McKesson Israel will be responsible for contacting foreign consignees.
- Root cause
- Software design (manufacturing process)
- Status
- Terminated
- Product code
- MWI
- Quantity affected
- 272 devices
- Distribution
- Worldwide distribution: US (nationwide) including states of: AR, CA, FL, DE, GA, HI, IL, IN, KS, LA, MA, MD, MN, MO, MS, MT, NJ, NV, OK, PA, SC, TNTX, , UT, WA; and countries of: Australia, Canada, Is
- Date initiated
- 2014-08-27
- Date posted
- 2014-10-08
- Date terminated
- 2016-05-18
- Location
- Alpharetta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MCKESSON CARDIOLOGY HEMO (K131497) | Mckesson Israel , Ltd. | 2013-12-05 |