Recall Z-0305-06 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Witt Biomedical Corporation
Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053.
| Date | Dec 23, 2005 (initiated Sep 16, 2005) |
| Status | Terminated |
| Reason | Customer complained that a boom monitor came off the boom. No patient or user injury was associated with the incident. |
| Root cause | Other |
| Action | Consignees will be notified of recall by phone, the firm will use a phone script. |
| Quantity | 1541 |
| Distribution | Products were distributed to approximately 672 medical facilities throughout the United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033030 | CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM Witt Biomedical Corp, Feb 24, 2004 |