GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device
FDA device recall Z-0788-2019 · posted 2019-01-30 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- Increased temperature in the probe-head surface with LOGIQ P6 Model BT07 and BT09 scanners when used in specific types of scans and with specific probes.
- Action taken
- The firm disseminated its medical device correction notices by letter on 12/28/2018. The letter recommends discontinuing scanning patients in endocavity, surgical, and neonatal exams and to discontinue the use of E8C, E8CS, BE9C, BE9CS, 4DE7C, i12L, 8C, 4D8C, 7S, 5S, and 5Sp probes.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 1,897 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2018-12-28
- Date posted
- 2019-01-30
- Date terminated
- 2020-10-05
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE LOGIQ P6 (K073297) | General Electric Co. | 2007-12-18 |