Spacelabs Medical Flat Panel Display is a touchscreen display, 19-inch thin film transistor liquid crystal display (TFT-
FDA device recall Z-0620-2011 · posted 2010-12-14 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare, Llc
- Reason for recall
- The power supply of the Spacelabs Medical Flat Panel Display may fail, causing the display to go blank.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXJ
- Quantity affected
- 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,
- Date initiated
- 2009-03-20
- Date posted
- 2010-12-14
- Date terminated
- 2011-06-13
- Location
- Issaquah, WA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY (K932724) | Spacelabs Medical, Inc. | 1993-11-05 |