510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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Z-0649-2010

Spacelabs Model 91370 SL 2600 Compact Monitor Spacelabs Medical patient monitors passively display data...

GE Healthcare / initiated 2009-11-06 / Terminated / root cause: design
FDA source (opens on fda.gov)

Spacelabs Healthcare, Incorporated began a recall of Spacelabs Model 91370 SL 2600 Compact Monitor Spacelabs Medical patient monitors passively display data generated from Spacelabs Medical patient parameter... on . The reason FDA records is "Potential for monitor to shut down and not being able to power on again". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0649-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GE Healthcare
Product
Spacelabs Model 91370 SL 2600 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.
Product code
DXJ Display, Cathode-Ray Tube, Medical
Reason for recall
Potential for monitor to shut down and not being able to power on again.
Root cause tag
design
FDA root cause
Component design/selection
Action
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.
Quantity in commerce
968 units
Distribution
Worldwide Distribution
Product codes and lots
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