Z-0422-05

Ultraview Universal Clinical Workstation System Model 90385

Name: Z-0422-05 Ultraview Universal Clinical Workstation System Model 90385
Creator: Spacelabs Medical Incorporated
Published: 2005-01-07
License: https://open.fda.gov/license/

GE Healthcare / initiated 2005-01-07 / Terminated

FDA source

Spacelabs Medical Incorporated began a recall of Ultraview Universal Clinical Workstation System Model 90385 on 2005-01-07. The reason FDA records is "Weakness of the swivel base for the universal clinical workstation may result in the unit falling from its mounted position endangering users and patients". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0422-05
Status: Terminated
Initiated: 2005-01-07
Posted: 2005-01-25
Terminated: 2011-01-17
Recalling firm: GE Healthcare
Product: Ultraview Universal Clinical Workstation System Model 90385.
Product code: DXJ Display, Cathode-Ray Tube, Medical
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.
FDA 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 in commerce: 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 3000 units worldwide are still in operation with the Revision M or earlier base.
Product codes and lots: Universal Ultraview Clinical Workstation Model 90385 base versions with Revision M or earlier. This recall involves certain units within the serial number range SN: 385-000337 to SN: 385-111440. The firm indicated that not all serial numbers within this range are affected by this recall, but only those units with the specified Revision M or earlier base which have not already been updated.

Product code DXJ

K932724Class IISpacelabs Medical Integrated Clinical DisplaySpacelabs Medical, Inc. / cleared 1993-11-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)