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U.S. Department of Health and Human Services

Class 2 Device Recall Dinalink

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 Class 2 Device Recall Dinalinksee related information
Date Initiated by FirmJanuary 27, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on October 05, 2009
Recall NumberZ-1015-04
Recall Event ID 28997
Product Classification Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) - Product Code MHX
ProductDinalink brand Communication Cable which is an accessory to a medical device Dinalike which is an isolated protocol converter used to concert the serial data from a DINAMAP Monitor to that of the APEXPRO telemetry transmitter.
Code Information No serial numbers but the Dinalink protocol converter and cable has the product identifier of ''ILC1931''
FEI Number 1030184
Recalling Firm/
Manufacturer		 GE Medical Systems Information Technologies
4502 Woodland Corporate Blvd
Tampa FL 33614-2422
For Additional Information ContactThomas English
813-887-2107
Manufacturer Reason
for Recall		The potential exists for external electrical noise to be processed as irregular pacing thereby masking potential asystole events.
FDA Determined
Cause 2		Other
ActionThe firm mailed an 'Urgent Medical Device Correction' letter to consignees on January 27, 2004 advising them of the external electrical noise problem and informing them to not use the Dinalink ILC1931 with patients with pace makers until a fix or replacement can be provided. By 5/17/2004 corrective replacement cables had been provided to all consignees.
Quantity in Commerce36
DistributionProduct was distributed to 7 domestic hospitals in PA, SC, GA, FL, WI, SD AND WY.
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.
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