Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or ala

FDA device recall Z-0351-2014 · posted 2013-11-18 · Terminated

Recall details

Recalling firm

Spacelabs Healthcare, Llc

Reason for recall

Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component.

Action taken

Spacelabs Healthcare sent the "URGENT -MEDICAL DEVICE CORRECTION Spacelabs Healthcare qube Compact Monitor" letter, dated 01 November 2013, to the US consignees/customers on November 1, 2013. Spacelabs Healthcare will send the customer letter (translated as necessary) to all international subsidiaries and distributors of record via email on November 6, 2013. The letter described the product, problem and actions to be taken. The customers were instructed to advise staff of the potential for the monitor to fail to turn ON. Spacelabs Healthcare will contact their customers at the earliest possible date to schedule a convenient time for Spacelabs to correct all of your facility's affected monitors at no cost. If you have any questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MHX

Quantity affected

54 units total (42 units in the US and 12 outside US)

Distribution

Worldwide distribution: US (nationwide) including states of: Georgia, Idaho, New York, Oklahoma, Tennessee, Texas, and Wyoming and in countries of: Bahrain, Canada, France, Great Britain, Poland, and

Date initiated

2013-10-17

Date posted

2013-11-18

Date terminated

2014-04-02

Location

Snoqualmie, WA

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