Devices

Device Recall Ultraview Universal Clinical Workstation (UCW) Model 90385

Model / Serial
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 Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
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 Description
Ultraview Universal Clinical Workstation System Model 90385.
Manufacturer
Spacelabs Medical Incorporated
1 Event
- Recall of Device Recall Ultraview Universal Clinical Workstation (UCW) Model 90385

Manufacturer

Spacelabs Medical Incorporated

Manufacturer Address
Spacelabs Medical Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
Source
USFDA

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