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Terminated

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

FDA Recall Z-0305-06 · Posted 2005-12-23

Recalling FirmWitt Biomedical Corporation
Recall StatusTerminated
Product CodeMWI
Date Initiated2005-09-16
Date Terminated2012-07-11
Product Quantity1541

Reason for Recall

Customer complained that a boom monitor came off the boom. No patient or user injury was associated with the incident.

Firm Action

Consignees will be notified of recall by phone, the firm will use a phone script.

Root Cause

Other

Distribution Pattern

Products were distributed to approximately 672 medical facilities throughout the United States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033030CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEMWitt Biomedical Corp · 2004-02-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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