FDA Recall Terminated

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

Recall: Z-0324-2008 · Initiated June 27, 2007

Recall

Recall Number: Z-0324-2008
Event Number: 38368
Firm: Mini-Mitter Company, Inc.
FEI Number: 3007223238
Product Code: M
Status: Terminated
Root Cause: Software design
Initiated: June 27, 2007
Posted: January 17, 2008
Terminated: October 20, 2010
Address: 20300 Empire Ave, Ste B3, Bend, OR, 97701

Description

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.

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 quarantined, decontaminated, and repaired. Min-Mitter will rework all the devices returned. Each will have a new memory chip installed, be re-calibrated, retested, and have a new battery installed if required. Min-Mitter will provide a new one year warranty.

Distribution

Worldwide

Quantity

635