GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
FDA device recall Z-2201-2013 · posted 2013-09-16 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has recently become aware of an issue associated with the CARESCAPE Monitor B850 when used with the iCentral network. The iCentral must have the alarm management software license (L-NETM-00) and the alarm limit change option enabled to experience this issue. When changing the HR, SpO2 or Invasive pressure alarm limits from the iCentral over the network, the alarm priority on th
- Action taken
- Consignees were sent on 7/20/2011 a GE Healthcare "Important Product Information" letter. The letter was addressed to Healthcare Administrator / Risk Manager, chief of Nursing and Director of Biomedical Engineering. The letter described the Issue, Affected Product Details, Instructions, Product Correction, and Contact Information (Technical Support 1-800-558-7044).
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 636 (53 US, 583 OUS)
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of CA, CO, CT, HI, IL , IA, KY, LA, MA, MI, NE, NY,OH, OK, TX, and WI, and the countries of UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, T
- Date initiated
- 2011-07-20
- Date posted
- 2013-09-16
- Date terminated
- 2013-10-25
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARESCAPE MONITOR B850 (K092027) | Ge Medical Systems Information Technologies | 2009-08-28 |