GE LOGIQ P6 Ultrasound System. The device is intended for use by a qualified physician for the evaluation of soft tissue
FDA device recall Z-0834-2012 · posted 2012-01-21 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- GE Healthcare has recently become aware of a safety issue associated with the Probe of your LOGIC P6 system that may impact patient safety. GE Logic P6 probe head has a possibility to cause burn injuries to patients or operators.
- Action taken
- GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated December 23, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the affected product. Contact the GE Support Center at 1-800-321-7937 or your local GE Healthcare service representative for questions regarding this issue.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 2270
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KY, LA, ME, MA, MI, MN, MS, MO, MT, NE, NV, NH, NY, NC, ND, OH, OK, OR, PA, PR, RI, SC,
- Date initiated
- 2011-12-23
- Date posted
- 2012-01-21
- Date terminated
- 2014-01-21
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE LOGIQ P6 (K073297) | General Electric Co. | 2007-12-18 |