Spacelabs Medical Incorporated

All serial numbers involved

Obstetrical and Gynecological Devices

2

No

Distribution was to 44 medical facilities/hospitals nationwide.

BirthNet OB Data Management System 91861

Lot codes: 31942, 34956, 35209, 35296, 35747, 36239, 36555 Part number: 012-0123-01

Cardiovascular Devices

2

No

Cables were distributed to 9 US hospitals/medical centers and 30 international customers.

Tru-Link DIN unshielded ECG cable, 5-lead

All systems - each major component has its own serial number

Cardiovascular Devices

2

No

The systems were distributed to 22 hospitals/medical centers nationwide and to 2 Spacelabs personnel. There is no international distribution.

Spacelabs Medical 1400 MHz Telemetry System,. Model 91341-09. Telemetry System consists of Model 91341-09 transmitter, 90478-1CST receiver and 90478-1CSV receiver.

Model 91517 Lot BMP007559

Anesthesiology Devices

2

No

8 units shipped to France, 1 unit to Brussels, Belgium, and 2 units to a medical center in WY.

Ultraview SL Capnography Module, Model 91517 || A mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient''s ventilatory, circulatory, and metabolic status.

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.

Cardiovascular Devices

2

No

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.

Ultraview Universal Clinical Workstation System Model 90385.