Recall Z-0664-2020 ยท GXD Generator, Lesion, Radiofrequency
Abbott Medical
Radiofrequency Grounding Pad, REF RF-DGP-L
| Date | Oct 14, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | The firm initiated the recall by letter hand delivered by an Abbott field representative. The letter requested that consignee cease use of the affected lot and return the product with the aid of a field representative. |
| Quantity | 8940 devices |
| Distribution | nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111576 | NT 2000 LESIONING GENERATOR Neuro Therm, Inc., Sep 20, 2011 |