Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053.
FDA device recall Z-0305-06 · posted 2005-12-23 · Terminated
Recall details
- Recalling firm
- Witt Biomedical Corporation
- Reason for recall
- Customer complained that a boom monitor came off the boom. No patient or user injury was associated with the incident.
- Action taken
- Consignees will be notified of recall by phone, the firm will use a phone script.
- Root cause
- Other
- Status
- Terminated
- Product code
- MWI
- Quantity affected
- 1541
- Distribution
- Products were distributed to approximately 672 medical facilities throughout the United States.
- Date initiated
- 2005-09-16
- Date posted
- 2005-12-23
- Date terminated
- 2012-07-11
- Location
- Melbourne, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM (K033030) | Witt Biomedical Corp | 2004-02-24 |