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U.S. Department of Health and Human Services

Class 2 Device Recall ElectriCord

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 Class 2 Device Recall ElectriCordsee related information
Date Initiated by FirmApril 30, 2003
Date PostedOctober 15, 2003
Recall Status1 Terminated 3 on May 03, 2012
Recall NumberZ-0011-04
Recall Event ID 26293
510(K)NumberK012915 K020022 K021435 
Product Classification Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) - Product Code MWI
ProductPower 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.
Code Information Lot numbers 01-08 through 02-16 which are embossed into the power cord metal blades and also those with no lot numbers.
Recalling Firm/
Manufacturer		 GE Medical Systems Information Technologies
4502 Woodland Corporate Blvd.
Tampa FL 33614
For Additional Information ContactThomas English
813-887-2107
Manufacturer Reason
for Recall		Reports of broken plug ground pins on AC power cords for patient monitors.
FDA Determined
Cause 2		Component design/selection
ActionThe 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 Commerce16,339 Power Cords
DistributionThe recalled AC power cords were distributed to approximately 2600 Domestic hospital accounts nationwide and 180 international accounts.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MWI
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