Recall Z-0182-2014 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Urologix, Inc.
Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide. The Prostiva RF Model 8929 Hand Piece Kit is the delivery system component of the Prostiva RF Therapy System. Prostiva RF Therapy delivers low-levels of radiofrequency (RF) energy directly into the hyperplastic tissue for the treatment of benign prostatic hyperplasia (BPH). The RF energy delivered by the syste
| Date | Nov 8, 2013 (initiated Oct 21, 2013) |
| Status | Terminated |
| Reason | A Hand Piece high deployment force exceeded the maximum specification. |
| Root cause | Process change control |
| Action | Consignees were sent a Urologix Urgent Medical Device Recall letter dated October 21, 2013. The letter described the problem and the device involved in the recall. Advised consignees to examine their inventory and remove the recalled product. Requested consignees to complete and fax the "Customer Acknowledgement Form" to Hope Przybilla at 763-475-1443 or call her for questions. The consignees local representatives will be personally assisting them with the return process and ensuring that replacement product is offered and received promptly. |
| Quantity | 142 |
| Distribution | Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, KY, MA, MN, NC, NJ, NV, NY, OH, OR, TN, TX, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113380 | PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR Medtronic, Inc., Nov 15, 2012 |