Recall Z-0620-2011 ยท DXJ Display, Cathode-Ray Tube, Medical
Spacelabs Healthcare, Llc
Spacelabs Medical Flat Panel Display is a touchscreen display, 19-inch thin film transistor liquid crystal display (TFT-LCD). The PNs are 010-1619-00 and 010-1655-00, Models 94260-19 and 94256.
| Date | Dec 14, 2010 (initiated Mar 20, 2009) |
| Status | Terminated |
| Reason | The power supply of the Spacelabs Medical Flat Panel Display may fail, causing the display to go blank. |
| Root cause | Other |
| Action | Spacelabs Healthcare sent an URGENT: MEDICAL DEVICE RECALL Spacelabs Medical Flat Panel Power Supply PNs: 010-1619-00 & 010-1655-00 letter dated March 20, 2009 to US consignees. On March 27, 2009, Spacelabs sent the same recall letter with translation option to their international consignees.The letter stated the firm would be sending a replacement power supply. While waiting for the replacement of the power supply, Spacelabs Medical recommended their consignees brief the staff on the possibility of the display going blank to help prevent any adverse event from happening. The consignees were |
| Quantity | 2877 units in US and 731 units outside US |
| Distribution | Worldwide Distribution: USA in the following states: AK, AL, AR, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY, and including the following countries: AUSTRALIA, AUSTRIA, CANADA, |
| 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 |