FDA Device Recall Z-0011-04: GE Medical Systems Information Technologies

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0011-04.

Recall Res Number

Z-0011-04

Recalling Firm / Manufacturer

GE Medical Systems Information Technologies

FEI Number

1030184

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2003-04-30

Date Posted

2003-10-15

Date Terminated

2012-05-03

Product Code

MWI

Event Number

26293

Product Quantity

16,339 Power Cords

Product Description 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.

Reason for Recall Reports of broken plug ground pins on AC power cords for patient monitors.

Action Details 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.

Distribution Pattern The recalled AC power cords were distributed to approximately 2600 Domestic hospital accounts nationwide and 180 international accounts.

Code Information / Serial Numbers 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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Medical Device Recall: Z-0011-04

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer