Device product
Radiofrequency Grounding Pad, REF RF-DGP-L
Z-0664-2020
Product summary
- Firm
- Abbott Medical
- Event
- Event 84272
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8940 devices
- Official record key
device-enforcement:Z-0664-2020
Official wording
Reason: Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempting to remove this disposable release liner, a clear film may be left on the grounding pad which may interfere with patient skin contact and lead to uneven heating.
Code information: UDI: 05415067028914 Batch Numbers: 810319004, 810319005, and 810319021
Distribution pattern: nationwide
Derived failure modes
-
Unknown
Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempting to remove this disposable release liner, a clear film may be left on the grounding pad which may interfere with patient skin contact and lead to uneven heating.