Z-2270-2010

Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure. The Smart Disclosure product collects patient...

Name: Z-2270-2010 Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure. The Smart Disclosure product collects patient...
Creator: Spacelabs Healthcare, Incorporated
Published: 2008-10-17
License: https://open.fda.gov/license/

GE Healthcare / initiated 2008-10-17 / Terminated / root cause: design

FDA source

Spacelabs Healthcare, Incorporated began a recall of Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure. The Smart Disclosure product collects patient waveforms, alarms, vital signs and 12-lead reports. A... on 2008-10-17. The reason FDA records is "Potential for device to print out the wrong waveform data for the time indicated in the printout or display". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2270-2010
Status: Terminated
Initiated: 2008-10-17
Posted: 2010-08-25
Terminated: 2010-09-29
Recalling firm: GE Healthcare
Product: Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure. The Smart Disclosure product collects patient waveforms, alarms, vital signs and 12-lead reports. A 24-hour waveform acquisition is standard, with an upgrade option to 72 hours. The product provides basic trends in both tabular and graphical format, along with a retrospective ECG analysis. The analysis may be defined by patient, and the data may be presented in multiple formats, including a rhythm, a histogram, and a summary view. Standard reports are available from Smart Disclosure, including saved events, disclosure, trends histogram and summary.
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: Potential for device to print out the wrong waveform data for the time indicated in the printout or display.
Root cause tag: design
FDA root cause: Device Design
Action: On 07/17/2008, Spacelabs Healthcare began sending the MEDICAL DEVICE CORRECTION letter to their consignees. The letter informs the consignees that there is an issue involving ICS G2 Smart Disclosure (Model 92810) which causes the display or printing of an incorrect waveform for the time indicated in the printout or display. The consignees are advised whether to discontinue to use the device until the firm upgrades the system. If the consignees decide to continue to use the device, then they should discontinue any use of the "Refresh" button. When they print or view waveform reports,t hey should utilize the Saved Event view functionality of the product rather than Arrhythmia, Alarm or Waveform Views. If the printing from the Arrhythmia, Alarm, or Waveform views, the consignees must visually inspect the print out and verify that the waveform contains what you expected to see printed. The consignees could contact Spacelabs Healthcare at 1-800-522-7052 or 1-425-657-7200, x5089 for any questions about the corrective actions of the affected device. The firm's field service engineer will make a schedule a mutually agreeable time with the consignees to update the ICS G2 system at free of charge.
Quantity in commerce: 135 units
Distribution: Worldwide Distribution -- US, Turkey, Chile, Brazil, Netherlands, Puerto Rico, Switzerland, Australia, Czech Republic, Canada, Italy, Singapore, France, Germany, and Israel.
Product codes and lots: Software version V04.00.02 was shipped on 06/30/2008. The 92810 is a software application installed on an off-the-shelf computer and is not serialized. Spacelabs uses software versions and ship dates for identification and traceability purposes.

Product code DQK

K063490Class IISpacelabs Medical Full Disclosure System, Model 91810Spacelabs Medical, Inc. / cleared 2007-03-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)