Ultraview SL Patient Monitor, Model 91387. All modules may be affected except Models 90470, 90478, 90496, & 91496. Affec

FDA device recall Z-2134-2011 · posted 2011-05-03 · Terminated

Recall details

Recalling firm

Spacelabs Healthcare, Llc

Reason for recall

The circuit that supplies backup power to the modules in the Medical Patient Monitor, Model 91387, is not working. If there is a power interruption, the three-minute backup may not be operational and customers may lose any changes they have made to the alarm settings.

Action taken

SPACELABS Healthcare sent an Urgent Medical Device Correction letter dated April 1, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to weigh the benefits versus the risks when deciding whether or not to continue to use their monitors until they can be upgraded. Customers were recommended to brief their staff about the possibility of losing changes to the alarm settings and to restore them after a power interruption. Field service engineers will contact customers to schedule a mutually agreeable time to come to their hospital and upgrade their affected patient monitors at no cost to the hospital. US Consignees can call 1-800-522-7025, Select 2 for Technical Support. Consignees outside of the US can call 1-425-657-7200 x5089 for any questions about this recall.

Root cause

Other

Status

Terminated

Product code

MHX

Quantity affected

4470 units total (1894 units in US and 2579 units internationally)

Distribution

Worldwide Distribution - USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, CZE

Date initiated

2011-03-24

Date posted

2011-05-03

Date terminated

2012-02-15

Location

Issaquah, WA

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