Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming Sy
FDA device recall Z-1511-2020 · posted 2020-03-03 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- 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.
- Action taken
- The 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- LWS
- Quantity affected
- 4 devices
- Distribution
- US Nationwide distribution in the states of NC, TN, and MO.
- Date initiated
- 2020-02-12
- Date posted
- 2020-03-03
- Date terminated
- 2023-04-14
- Location
- Saint Paul, MN
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