Company: Spacelabs Medical, Inc
Date of Enforcement Report: 10/9/02
Class: II
PRODUCT
Recall # Z-1395-2/Z-1401-2.
a) Telemetry Digital Processors Models 90342, 90344,
90346, 90348. Recall # Z-1395-2/Z-1398-2;
b) Integrated Multiparameter Module Model 90470.
Recall # Z-1399-2;
c) Telemetry Receiver Module Model 90478.
Recall # Z-1400-2;
d) Ultarview Command Module Model 90496.
Recall # Z-1401-2.
REASON
ECG software fails to detect low heart rates in range of 12 to 15 bpm.
CODE
a) Models 90342, 90344, 90346, 90348 –
software version 3.05.17EN
b) Model 90470 – software version 2.02.30EN
c) Model 90478 – software version 3.02.02EN
d) Model 90496 – software version 1.02.08EN.
RECALLING FIRM/MANUFACTURER
Spacelabs Medical, Inc., Redmond, WA, by letter on October 22, 2001. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
69,293 to domestic consignees and 38,769 to international consignees.
DISTRIBUTION
Nationwide and Internationally.
