Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE Healthcare 8880 Gorman Road La
FDA device recall Z-0914-2014 · posted 2014-02-03 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
- Action taken
- GE Healthcare notified end users with a letter flagged as Urgent Medical Device Correction letter on 12/12/2013. The notification advised that GE Healthcare has become aware of a potential safety issue associated with the loosening of the blender knob shaft on all Resuscitation units. The firm advised that accounts ensure that all potential users in their facility are made aware of this safety notification and the recommended actions described in the notification: 1. Perform blender accuracy check as outlined in Section 2.5-2.5.1 of the Service Manual to verify that the O2 concentration set at 21% is within 16-26% O2 and the concentration at 100% setting is within the recommended range (95-105% O2). 2. If the blender accuracy test results do not meet specifications, remove the unit from patient use and contact a GE Healthcare Service Representative at the number listed below. 3. If the blender accuracy check passes in Step 1 above, you may continue to use your resuscitation system. The following precautions are recommended to ensure blender accuracy is maintained between system checks. Use an independent oxygen analyzer, as determined by your hospital policy, to check blended Air/O2 accuracy. When delivering Oxygen, use a pulse oximeter to monitor your patient. Customers were requested to contact a GE Healthcare Service Representative at 1-800-345-2700 to arrange for correction if the device is found to be defective.
- Root cause
- Process control
- Status
- Terminated
- Product code
- BTM
- Quantity affected
- 15 units
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Uruguay, Venezuela, Albania, Algeria, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Canada, Chile, China, C
- Date initiated
- 2013-12-12
- Date posted
- 2014-02-03
- Date terminated
- 2015-06-01
- Location
- Laurel, MD
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM (K070247) | Ohmeda Medical | 2007-04-20 |