Z-0326-2008

Actiwatch 64 AM, Bandless Part Number 198-0301-AM1, Respironics, Inc., Mini Mitter, a Respironics Company...

Name: Z-0326-2008 Actiwatch 64 AM, Bandless Part Number 198-0301-AM1, Respironics, Inc., Mini Mitter, a Respironics Company...
Creator: Mini-Mitter Company, Inc.
Published: 2007-06-27
License: https://open.fda.gov/license/

Mini-Mitter Co., Inc. / initiated 2007-06-27 / Terminated / root cause: software

FDA source

Mini-Mitter Company, Inc. began a recall of Actiwatch 64 AM, Bandless Part Number 198-0301-AM1, Respironics, Inc., Mini Mitter, a Respironics Company, Bend, Oregon on 2007-06-27. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0326-2008
Status: Terminated
Initiated: 2007-06-27
Posted: 2008-01-17
Terminated: 2010-10-20
Recalling firm: Mini-Mitter Co., Inc.
Product: Actiwatch 64 AM, Bandless Part Number 198-0301-AM1, Respironics, Inc., Mini Mitter, a Respironics Company, Bend, Oregon
Product code: M
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.
Root cause tag: software
FDA 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 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.
Quantity in commerce: 20
Distribution: Worldwide
Product codes and lots: Serial Numbers: V960132, V960133, V960135, V960191, V960253, V960254, V960255, V960256, V960257, V960314, V960460, V960461, V960469, V960481, V960483, V960487, V960488, V960504, V960505, and V960550

Product code M

K983533Class IIActiwatchMini-Mitter Co., Inc. / cleared 1999-03-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)