Recall Z-0647-2010
Spacelabs Healthcare, Incorporated · initiated November 6, 2009
Product
Spacelabs Model 91367 SL 2200 Compact Monitor Spacelabs Medical patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products.
Codes / lots: S/N, U.S. Domestic units: 1367-000395, 1367-000396, 1367-000397, 1367-000628, 1367-000629, 1367-000630, 1367-000631, 1367-000632, 1367-000633, 1367-000522, 1367-000525, 1367-000526, 1367-000527, 1367-000601, 1367-000602, 1367-000603, 1367-000604, 1367-000605, 1367-000606, 1367-000477, 1367-000731, 1367-000732, 1367-000733, 1367-000734, 1367-000444, 1367-000831, 1367-000832, 1367-000833, 1367-000437, 1367-000438, 1367-000272, 1367-000454, 1367-000482, 1367-000483, 1367-000433, 1367-000434, 1367-000435, 1367-000436, 1367-000479, 1367-000480, 1367-000481, 1367-000524, 1367-000399, 1367-000400, 1367-000411, 1367-000412, 1367-000735, 1367-000736, 1367-000737, 1367-000738, 1367-000739, 1367-000740, 1367-000741, 1367-000742, 1367-000743, 1367-000744, 1367-000745, 1367-000746, 1367-000747, 1367-000748, 1367-000749, 1367-000439, 1367-000440, 1367-000441, 1367-000442, 1367-000443, 1367-000523, 1367-000530, 1367-000531, 1367-000532, 1367-000663, 1367-000664, 1367-000665, 1367-000691, 1367-000692, 1367-000693, 1367-000694, 1367-000695, 1367-000696, 1367-000697, 1367-000698, 1367-000699, 1367-000700, 1367-000701, 1367-000702, 1367-000703, 1367-000704, 1367-000705, 1367-000706, 1367-000707…
Reason for recall
Potential for monitor to shut down and not being able to power on again.
FDA-determined cause: Component design/selection
Action taken
On 11/6/09 the firm sent Urgent - Device Correction notifications to customers by certified mail informing them of the monitor failure and that a field service engineer will contact the customer to fix the affected device at no cost. On 11/13/2009 the firm's Global Tech Support sent notification via email to all foreign subsidiaries and distributors informing them of the monitor failure and that a field service engineer will contact the customer to fix the affected device at no cost. Questions are to be directed to Spacelabs Medical's Technical Support at 1-800-522-7025, and 1-425-657-7200 x5089 for those customers outside of the US.
Details
- Recall number
- Z-0647-2010
- Initiated
- November 6, 2009
- Posted by FDA
- January 19, 2010
- Terminated
- July 21, 2011
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Quantity
- 422 units
- Distribution
- Worldwide Distribution
- Recalling firm
- Spacelabs Healthcare, Incorporated, Issaquah, WA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0648-2010 | Spacelabs Model 91369-24 SL 2400 Compact Monitor Spacelabs Medical patient monitors…Potential for monitor to shut down and not being able to power on again. | 11/06/2009Terminated |
| Z-0649-2010 | Spacelabs Model 91370 SL 2600 Compact Monitor Spacelabs Medical patient monitors…Potential for monitor to shut down and not being able to power on again. | 11/06/2009Terminated |