Recall of Ultraview SL Command Modules with the Masimo SpO2

Recall

71118

Class 2

Z-1577-2015

2015-04-21

2015-05-04

Terminated

United States

2015-11-16

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136155

Modules resetting. this failure mode happens when the spacelabs command module is configured with the masimo spo2 option (-m), the spacelabs respiration option (-r) and the masimo spo2 pcba, pn: 010-1136-02. with these two options and the masimo spo2 pcba present, the module may experience random resets.

Spacelabs expanded the recall to include additional 29 units and notified one additional new consignee on June 4, 2015. ******************************************************************************************* The firm, Spacelabs Healthcare, sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated 27 April 2015, via priority mail to US consignees and email to foreign consignees. The letter described the product, problem and actions to be taken. The consignees were instructed to circulate this notification to all persons concerned by the information it contains; add a copy to the appropriated system user manuals until such time as corrections have been implemented by Spacelabs, and weigh the benefits versus the risks when deciding whether or not to continue to use your modules until they can be upgraded. Only modules shipped or repaired after March 8, 2014 are affected by this recall. Affected command modules will be upgraded with a new version of software by Spacelabs at no cost. Customer with questions about this corrective action, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.