Recall Z-0324-2008 ยท M
Mini-Mitter Company, Inc.
Actiwatch 16 Part Number 198-0300-00, Actiwatch 16 AM 198-0300-AM; Actiwatch 64 Part Number 198-0301-00; Actiwatch 64 AM Part Number 198-0301-AM, Mini Mitter, a Respironics Company, Bend, Oregon
| Date | Jan 17, 2008 (initiated Jun 27, 2007) |
| Status | Terminated |
| Reason | Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. If left unaddressed, the issues can lead to permanent communication failure. |
| Root cause | Software design |
| Action | A Voluntary Medical Device Recall letter dated June 26, 2007. The recall letter will instruct the customers to 1) fill out a business reply form to confirm contact information and devices serial numbers in their possession. Then FAX this info back immediately to Stericycle or Mini-Mitter. 2) Refer to the work scheduled rework date reserved for them and noted in their recall notification letter and return the device for service at that time; and 3) Package the device appropriately, insure it and return it via UPS using the provided UPS shipping label. Product returned to Mini-Mitter will be qu |
| Quantity | 635 |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983533 | ACTIWATCH Mini-Mitter Co., Inc., Mar 23, 1999 |