Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053.
This recall has been terminated (originally issued December 23, 2005).
- Company
- Witt Biomedical Corporation
- Recall Initiated
- September 16, 2005
- Posted
- December 23, 2005
- Terminated
- July 11, 2012
- Recall Number
- Z-0305-06
- Quantity
- 1541
- Firm Location
- Melbourne, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Customer complained that a boom monitor came off the boom. No patient or user injury was associated with the incident.
Distribution
Products were distributed to approximately 672 medical facilities throughout the United States.
Lot / Code Info
Serial numbers 970424D to 200501499.
Root Cause
Other
Action Taken
Consignees will be notified of recall by phone, the firm will use a phone script.