Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0011-04

Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors...

GE Medical Systems Information Technologies, Inc. / initiated 2003-04-30 / Terminated / root cause: design

GE Medical Systems Information Technologies began a recall of Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000... on . The reason FDA records is "Reports of broken plug ground pins on AC power cords for patient monitors". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0011-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GE Medical Systems Information Technologies, Inc.
Product
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.
Product code
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Reason for recall
Reports of broken plug ground pins on AC power cords for patient monitors.
Root cause tag
design
FDA root cause
Component design/selection
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.
Quantity in commerce
16,339 Power Cords
Distribution
The recalled AC power cords were distributed to approximately 2600 Domestic hospital accounts nationwide and 180 international accounts.
Product codes and lots
Lot numbers 01-08 through 02-16 which are embossed into the power cord metal blades and also those with no lot numbers.