Recall Z-0422-05 ยท DXJ Display, Cathode-Ray Tube, Medical
Spacelabs Medical Incorporated
Ultraview Universal Clinical Workstation System Model 90385.
| Date | Jan 25, 2005 (initiated Jan 7, 2005) |
| Status | Terminated |
| Reason | Weakness of the swivel base for the universal clinical workstation may result in the unit falling from its mounted position endangering users and patients. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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 accounts and 4,705 units were sold to 102 international accounts. The firm estimates approximately 3 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932724 | SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY Spacelabs Medical, Inc., Nov 5, 1993 |