Recall Z-0620-2011
Spacelabs Healthcare, Llc · initiated March 20, 2009
Product
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.
Codes / lots: Date Codes (WK numbers) identified on the affected power supplies: 0647, 0703, 0706, 0707, 0709, 0712, 0724, 0727, 0728 or 0732. Lot/Serial Numbers on the systems for US Consignees: ELZ-0011442, ELZ-0012143, ELZ-0013307, ELZ-0013557, ELZ-0014567, ELZ-0014570, ELZ-0014574, ELZ-0014577, ELZ-0014580, ELZ-0014583, ELZ-0014585, ELZ-0014586, ELZ-0014587, ELZ-0014590, ELZ-0014591, ELZ-0014592, ELZ-0014593, ELZ-0014594, ELZ-0014595, ELZ-0014596, ELZ-0014597, ELZ-0014598, ELZ-0014599, ELZ-0014600, ELZ-0014601, ELZ-0014603, ELZ-0014604, ELZ-0014605, ELZ-0014606, ELZ-0014607, ELZ-0014608, ELZ-0014609, ELZ-0014610, ELZ-0014611, ELZ-0014612, ELZ-0014613, ELZ-0014614, ELZ-0014615, ELZ-0014616, ELZ-0014617, ELZ-0014618, ELZ-0014619, ELZ-0014620, ELZ-0014621, ELZ-0014622, ELZ-0014623, ELZ-0014625, ELZ-0014626, ELZ-0014629, ELZ-0014630, ELZ-0014631, ELZ-0014632, ELZ-0014633, ELZ-0014634, ELZ-0014635, ELZ-0014636, ELZ-0014637, ELZ-0014638, ELZ-0014639, ELZ-0014640, ELZ-0014641, ELZ-0014645, ELZ-0014648, ELZ-0014656, ELZ-0014657, ELZ-0014658, ELZ-0014718, ELZ-0014719, ELZ-0014720, ELZ-0014723, ELZ-0014724, ELZ-0014726, ELZ-0014727, ELZ-0014729, ELZ-0014731, ELZ-0014733, ELZ-0014736, ELZ-0014737…
Reason for recall
The power supply of the Spacelabs Medical Flat Panel Display may fail, causing the display to go blank.
FDA-determined cause: Other
Action taken
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 advised to dispose the old power supply per their premise protocol or local regulations. The consignees from US can contact Spacelabs Medical at 1-800-522-7025, #2 for Technical Support , and consignees outside the United States can call 1-425-657-7200 x5089 for any questions about the recall.
Details
- Recall number
- Z-0620-2011
- Initiated
- March 20, 2009
- Posted by FDA
- December 14, 2010
- Terminated
- June 13, 2011
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- 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, Caribbean, CZECH REPUBLIC, EGYPT, ESTONIA, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, ISRAEL…
- Recalling firm
- Spacelabs Healthcare, Llc, Issaquah, WA