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

FDA device recall Z-2270-2010 · posted 2010-08-25 · Terminated

Recall details

Recalling firm

Spacelabs Healthcare, Incorporated

Reason for recall

Potential for device to print out the wrong waveform data for the time indicated in the printout or display.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

DQK

Quantity affected

135 units

Distribution

Worldwide Distribution -- US, Turkey, Chile, Brazil, Netherlands, Puerto Rico, Switzerland, Australia, Czech Republic, Canada, Italy, Singapore, France, Germany, and Israel.

Date initiated

2008-10-17

Date posted

2010-08-25

Date terminated

2010-09-29

Location

Issaquah, WA

Related 510(k) clearances