Prolieve Thermodilatation System, model number M0068808000, labeled in part***Distributed by Boston Scientific Corporati
FDA device recall Z-1339-04 · posted 2004-08-11 · Terminated
Recall details
- Recalling firm
- Celsion Corporation
- Reason for recall
- Software controlling a medical device for patient treatment may malfunction and cause thermal injury to patient.
- Action taken
- Celsion Corporation ceased distribution of the device 6/25/04 and implemented a field correction by company representatives at end user facilities on 6/25/04 consisting of computer clock reset. The firm subsequently notified end users on 7/19/04 by certified letter, which included a warning sticker to be placed on the device control screen. The notification and sticker instructed users not to use the device if there is a possibility of the computer clock transitioning through midnight during the procedure.
- Root cause
- Other
- Status
- Terminated
- Product code
- MEQ
- Quantity affected
- 28 devices
- Distribution
- Devices were distributed to 19 medical facilities and physician end users nationwide by the recalling firm''s contract distributor.
- Date initiated
- 2004-07-19
- Date posted
- 2004-08-11
- Date terminated
- 2005-03-31
- Location
- Columbia, MD
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