GE Healthcare, ApexPro Telemetry System The ApexPro Telemetry System is intended for use under the direct supervision of
FDA device recall Z-1522-2011 · posted 2011-03-03 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has become aware of a potential for loss of patient monitoring when ApexPro Telemetry System is used in conjunction with a mirrored view CARESCAPE CIC Pro in combination monitoring mode (combo mode). The safety issue includes the potential for a delay in annunciation of audible alarms when used in combo mode, and may result in the delay of treatment of a cardiac event.
- Action taken
- GE sent an "Urgent Medical Device Correction" letter dated December 29, 2010. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Affected Product Details, Product Correction, Safety Instruction and Contact Information. Customers were instructed to contact Technical Support or their local Service Representative with any questions regarding this medical device. For any questions regarding this recall call 262-573-4122.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 2346
- Distribution
- Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO,MT,NE, NJ, NM, NY, NC, OH, OK, OR, PA, PR, SC, TN, TX, UT, VT,
- Date initiated
- 2011-01-28
- Date posted
- 2011-03-03
- Date terminated
- 2012-05-29
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APEXPRO TELEMETRY SYSTEMS (K080251) | Ge Medical Systems Information Technologies | 2008-06-20 |