Recall Z-0694-2013 ยท DQK Computer, Diagnostic, Programmable
Spacelabs Healthcare, Llc
Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. 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 retro
| Date | Jan 17, 2013 (initiated Dec 5, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 wa |
| Quantity | 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 countries of Argentina, Mexico, France, and India. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110779 | SPACELABS SMART DISCLOSURE SYSTEM Spacelabs Healthcare, Apr 19, 2011 |