FDA Device

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

Hazard

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

What You Should Do

Remedy

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

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Products

Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053.
Brand
Witt Biomedical Corporation
UPC
Serial numbers 970424D to 200501499.

Units Affected

1541

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