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.
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