Recall Z-0288-2011 ยท DXJ Display, Cathode-Ray Tube, Medical
Spacelabs Healthcare, Incorporated
The product is a 19" Spacelabs Medical Flat Panel Display, Model 94260-19, manufactured by ELo Touchsystems
| Date | Nov 2, 2010 (initiated Oct 23, 2009) |
| Status | Terminated |
| Reason | The Spacelabs Medical Flat Panel Display, Model 94260-19 may fail prematurely and causing the screen to go blank. This inability to view data may result in delayed patient treatment. |
| Root cause | Other |
| Action | On 10/23/09, Spacelabs issued URGENT: MEDICAL DEVICE RECALL notification letters dated October 23, 2009 to their consignees. The notification states the recalled product as Spacelabs Medical 19" Flat Panel Display, Model 94260-19. The consignees are informed that there is a possibility that the internal power distribution circuit board will fail prematurely, causing the display to go blank. Audio alarms will continue to function normally. The firm's Field Service Engineer will be contacting the consignees to set up a convenient time to schedule the upgrades of the affected displays. Display |
| Quantity | 2560 units (2020 domestic, 540 international) |
| Distribution | Worldwide Distribution: USA in the states of AK, AL, AR, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WY, and the following countries: Australia, Austria, Canada, Czech Republic, Egypt, Fra |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932724 | SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY Spacelabs Medical, Inc., Nov 5, 1993 |