Z-0305-06

Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053

Name: Z-0305-06 Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053
Creator: Witt Biomedical Corporation
Published: 2005-09-16
License: https://open.fda.gov/license/

Invivo Corporation / initiated 2005-09-16 / Terminated

FDA source

Witt Biomedical Corporation began a recall of Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053 on 2005-09-16. The reason FDA records is "Customer complained that a boom monitor came off the boom. No patient or user injury was associated with the incident". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0305-06
Status: Terminated
Initiated: 2005-09-16
Posted: 2005-12-23
Terminated: 2012-07-11
Recalling firm: Invivo Corporation
Product: Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053.
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Reason for recall: Customer complained that a boom monitor came off the boom. No patient or user injury was associated with the incident.
FDA root cause: Other
Action: Consignees will be notified of recall by phone, the firm will use a phone script.
Quantity in commerce: 1541
Distribution: Products were distributed to approximately 672 medical facilities throughout the United States.
Product codes and lots: Serial numbers 970424D to 200501499.

Product code MWI

K033030Class IICalysto Series IV Patient Care Monitors and Central Station and ECG Management SystemWitt Biomedical Corp / cleared 2004-02-24

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)