Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia det

FDA device recall Z-0188-2014 · posted 2013-11-08 · Terminated

Recall details

Recalling firm

Spacelabs Healthcare, Llc

Reason for recall

Spacelabs Healthcare elance Vital Signs Monitor with Option S, model 93330, is recalled because the monitor will not permit connection of any of the Spacelabs TruLink line of SpO2 sensors.

Action taken

Spacelabs Healthcare sent the "URGENT -MEDICAL DEVICE CORRECTION Spacelabs Healthcare elance Vital Signs Monitor with Option S" letter, dated 01 November 2013, to the US consignee 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. USERS ARE ADVISED THAT: -They may not be able to monitor their patient's oxygen saturation because the monitor will not allow the TruLink SpO2 sensor to be connected. The clinician will be required to find an alternate method to monitor oxygen saturation. -They will be contacted at the earliest possible date to schedule a convenient time and Spacelabs will correct all of your facility's affected monitors at no cost. Customer in the US can call Spacelabs Healthcare, Inc. of Snoqualmie, Washington at 800-522-7025. If you have any questions about this corrective action program, please contact Spacelabs Healthcare at +86 512 87178304 for Technical Support.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MHX

Quantity affected

89 units total (1 in US and 88 International)

Distribution

Worldwide Distribution-Distributed in Puerto Rico and the countries of France, Indonesia, Korea, Nicaragua, Philippines, and Taiwan.

Date initiated

2013-10-17

Date posted

2013-11-08

Date terminated

2014-02-25

Location

Snoqualmie, WA

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