Ultraview Universal Clinical Workstation System Model 90385.
FDA device recall Z-0422-05 · posted 2005-01-25 · Terminated
Recall details
- Recalling firm
- Spacelabs Medical Incorporated
- Reason for recall
- Weakness of the swivel base for the universal clinical workstation may result in the unit falling from its mounted position endangering users and patients.
- Action taken
- All US customers were sent a Medical Device Recall letter on 1/7/2005 describing how to examine monitors for the defect and to discontinue use of any suspect unit s until examintaion by a Field Service Engineer . International customers will be notified via email or letter on 1/14/2005. Follow up contact by Customer Support and Global Support is planned for any customer not responding with a FAX-back form.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXJ
- Quantity affected
- 12,306 devices with this base style.
- Distribution
- The firm completed a survey of their customer records and determined a total of 12,306 units were installed from January of 1994 through December of 1997. 7,601 units were originally sold to 767 US ac
- Date initiated
- 2005-01-07
- Date posted
- 2005-01-25
- Date terminated
- 2011-01-17
- Location
- Issaquah, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY (K932724) | Spacelabs Medical, Inc. | 1993-11-05 |