Recall Z-2270-2010 ยท DQK Computer, Diagnostic, Programmable
Spacelabs Healthcare, Incorporated
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
| Date | Aug 25, 2010 (initiated Oct 17, 2008) |
| Status | Terminated |
| Reason | Potential for device to print out the wrong waveform data for the time indicated in the printout or display. |
| 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 |
| Quantity | 135 units |
| Distribution | Worldwide Distribution -- US, Turkey, Chile, Brazil, Netherlands, Puerto Rico, Switzerland, Australia, Czech Republic, Canada, Italy, Singapore, France, Germany, and Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063490 | SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810 Spacelabs Medical, Inc., Mar 15, 2007 |