Actiwatch 16, Basic Startup pkg 198-1010-00; and Actiwatch 64, Basic Startup pkg Part Number 198-1000-00.
FDA device recall Z-0327-2008 · posted 2008-01-17 · Terminated
Recall details
- Recalling firm
- Mini-Mitter Company, Inc.
- Reason for recall
- 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 taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- M
- Quantity affected
- 15
- Distribution
- Worldwide
- Date initiated
- 2007-06-27
- Date posted
- 2008-01-17
- Date terminated
- 2010-10-20
- Location
- Bend, OR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACTIWATCH (K983533) | Mini-Mitter Co., Inc. | 1999-03-23 |