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Terminated

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.

FDA Recall Z-0620-2011 · Posted 2010-12-14

Recalling FirmSpacelabs Healthcare, Llc
Recall StatusTerminated
Product CodeDXJ
Date Initiated2009-03-20
Date Terminated2011-06-13
Product Quantity2877 units in US and 731 units outside US

Reason for Recall

The power supply of the Spacelabs Medical Flat Panel Display may fail, causing the display to go blank.

Firm 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 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.

Root Cause

Other

Distribution Pattern

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, ITALY, JORDAN, KUWAIT, LEBANON, MEXICO, NETHERLANDS, PAKISTAN, PANAMA, POLAND, PUERTO RICO, SAUDI ARABIA, SINGAPORE, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED KINGDOM, and VENEZUELA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K932724SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAYSpacelabs Medical, Inc. · 1993-11-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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