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U.S. Department of Health and Human Services

Class 2 Device Recall LATITUDE Programming System

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 Class 2 Device Recall LATITUDE Programming Systemsee related information
Date Initiated by FirmFebruary 12, 2020
Date PostedMarch 03, 2020
Recall Status1 Terminated 3 on April 14, 2023
Recall NumberZ-1511-2020
Recall Event ID 85077
PMA NumberP910077S159 
Product Classification Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
ProductBoston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.
Code Information Serial Numbers: 008885, 010823, 010615, 007886
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
4100 Hamline Ave N Bldg 3
Saint Paul MN 55112-5700
For Additional Information Contact
800-227-3422
Manufacturer Reason
for Recall		Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe firm initiated the recall by letter on 12/12/2020. The letter explained the error and requested the consignee segregate the units for removal. The firm will provide another model of programmer to be used in the interim.
Quantity in Commerce4 devices
DistributionUS Nationwide distribution in the states of NC, TN, and MO.
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.
PMA DatabasePMAs with Product Code = LWS
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