Recall Z-0675-06 ยท MNB Device, Thermal Ablation, Endometrial
American Medical Systems
her option Cryoablation Therapy Disposable Probe, Model CU-1. Sterile. Manufactured at: American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA. The Her Option Cryoablation Therapy System consists of a Console, a Cryoprobe and a Disposable Probe.
| Date | Mar 23, 2006 (initiated Jan 13, 2006) |
| Status | Terminated |
| Reason | Overheating of the Cryoablation Therapy Disposable Probe (CU-1), could cause a burn injury to a patient or user in certain circumstances. |
| Root cause | Other |
| Action | An Urgent Device Recall / Product Safety Advisory letter, dated January 25, 2006, was sent to all customers who have purchased Disposable Probes since 01/01/2005 or who have in their possession a Her Option console (whether customer owned or AMS owned). The letter informs customers of the issue and of the 2 lots being recalled. The letter also includes Safety Advisory Instruction which are to be posted on or near the Her Option Console. A Recall Acknowledgement Form is asked to be returned to American Medical Systems which serves as an indication that the customer read the notice, is return |
| Quantity | 152 |
| Distribution | Nationwide. AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NJ, NM, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.