Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Versi

FDA device recall Z-0694-2013 · posted 2013-01-17 · Terminated

Recall details

Recalling firm

Spacelabs Healthcare, Llc

Reason for recall

Displaying or printing of an incorrect waveform for the time indicated in the printout or display in the Spacelabs Healthcare Intesys Clinical Suite (ICS) G2, Version 4.03, Clinical Access portion of Smart Disclosure, Model 92810.

Action taken

Spacelabs has sent the Urgent -Medical Device Correction Spacelabs Healthcare ICS G2 Version 4.03 Model 92810 Smart Closure letter, dated 19 December 2012, to all U.S. customers. The firm plans to send a customer letter (translated as necessary) via e-mail to all international subsidiaries and distributors of record on December 27, 2012. The letter is addressed to Hospital Administrator/Biomedical Manager/Office Manager. Users are advised on the following actions: 1) Advise your staff of this potential failure and advise them to always click the "Refresh" button when scrolling to new waveform data prior to printing or viewing waveform information or storing saved events. 2) We will contact you at the earliest possible date to schedule a convenient time for your hospital to upgrade your affected software at no cost. Customers with questions can contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.

Root cause

Software design

Status

Terminated

Product code

DQK

Quantity affected

27 in US and 17 International

Distribution

Worldwide Distribution-USA including Puerto Rico and the states of California, Florida, Iowa, Illinois, Louisiana, Michigan, Minnesota, North Carolina, South Carolina, Texas, and Washington, and the c

Date initiated

2012-12-05

Date posted

2013-01-17

Date terminated

2013-07-08

Location

Issaquah, WA

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