Recall Z-0648-2010
Spacelabs Healthcare, Incorporated · initiated November 6, 2009
Product
Spacelabs Model 91369-24 SL 2400 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: 1369-011276, 1369-011277, 1369-009714, 1369-009715, 1369-011109, 1369-011110, 1369-011111, 1369-011112, 1369-011113, 1369-012059, 1369-012060, 1369-012061, 1369-012062, 1369-011556, 1369-011557, 1369-011558, 1369-011559, 1369-011560, 1369-011561, 1369-011253, 1369-010778, 1369-010779, 1369-010780, 1369-010781, 1369-010782, 1369-010783, 1369-010784, 1369-010785, 1369-010786, 1369-010787, 1369-010788, 1369-010789, 1369-010790, 1369-010791, 1369-010792, 1369-010793, 1369-010794, 1369-010795, 1369-010796, 1369-010797, 1369-010798, 1369-010799, 1369-010800, 1369-010801, 1369-010802, 1369-010803, 1369-010804, 1369-010805, 1369-011033, 1369-011034, 1369-011035, 1369-011036, 1369-011037, 1369-011038, 1369-011039, 1369-011040, 1369-011041, 1369-011042, 1369-011043, 1369-011044, 1369-011045, 1369-011046, 1369-011047, 1369-011048, 1369-011049, 1369-011050, 1369-011051, 1369-011052, 1369-011053, 1369-011054, 1369-011055, 1369-011056, 1369-011057, 1369-011058, 1369-011059, 1369-011060, 1369-011562, 1369-011563, 1369-011564, 1369-011565, 1369-011566, 1369-011567, 1369-011568, 1369-011569, 1369-011570, 1369-011571, 1369-011572, 1369-011573, 1369-011574, 1369-011575…
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-0648-2010
- Initiated
- November 6, 2009
- Posted by FDA
- January 19, 2010
- Terminated
- July 21, 2011
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Quantity
- 2,023 units
- Distribution
- Worldwide Distribution
- Recalling firm
- Spacelabs Healthcare, Incorporated, Issaquah, WA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0647-2010 | Spacelabs Model 91367 SL 2200 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 |