Spacelabs Healthcare, Llc: Medical Device Recall in 2013 - (Recall #: Z-0351-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications.

Product Classification:

Class II

Date Initiated: October 17, 2013

Date Posted: November 27, 2013

Recall Number: Z-0351-2014

Event ID: 66727

Reason for Recall:

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

Status: Terminated

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

Code Information:

SERIAL NUMBERS IN THE US: 1390-101940, 1390-101945, 1390-101946, 1390-101947, 1390-101948, 1390-101950, 1390-101951, 1390-101952, 1390-101953, 1390-101954, 1390-101955, 1390-101956, 1390-101957, 1390-101958, 1390-101962, 1390-101963, 1390-101971, 1390-101972, 1390-101973, 1390-101974, 1390-101979, 1390-101980, 1390-101994, 1390-102002, 1390-102003, 1390-102004, 1390-102005, 1390-102006, 1390-102007, 1390-102008, 1390-102009, 1390-102010, 1390-102011, 1390-102012, 1390-102013, 1390-102014, 1390-102015, 1390-102016, 1390-102017, 1390-102018, 1390-102019, and 1390-102020. SERIAL NUMBER INTERNATIONAL: 1390-101949, 1390-101969, 1390-101970, 1390-101975, 1390-101976, 1390-101977, 1390-101978, 1390-102001, 1390-102021, 1390-102022, 1390-102023, and 1390-102024.

Distribution Pattern:

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 The Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated