Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.
FDA Recall Z-0011-04 · Posted 2003-10-15
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Recalling FirmGE Medical Systems Information Technologies
Recall StatusTerminated
Product CodeMWI
Date Initiated2003-04-30
Date Terminated2012-05-03
Product Quantity16,339 Power Cords
Reason for Recall
Reports of broken plug ground pins on AC power cords for patient monitors.
Firm Action
The recalling firm mailed a Recall Notification Letter with response form and corretive power cords beginning on April 30, 2003 until August 14, 2003 as corrective cords became available. Consignees were instructed on how to determine if they have the recalled cords and to destroy any found by cutting the plug from the wire. Also corrective AC power cords were provided to each consignee.
Root Cause
Component design/selection
Distribution Pattern
The recalled AC power cords were distributed to approximately 2600 Domestic hospital accounts nationwide and 180 international accounts.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K021435DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410NGe Medical Systems Information Technologies · 2002-05-22K012915DINAMAP PRO 1000 MONITOR, MODEL 1000Ge Medical Systems Information Technologies · 2002-03-21K020022DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410Ge Medical Systems Information Technologies · 2002-02-01
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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