Z-1339-04

Prolieve Thermodilatation System, model number M0068808000, labeled in part***Distributed by Boston...

Name: Z-1339-04 Prolieve Thermodilatation System, model number M0068808000, labeled in part***Distributed by Boston...
Creator: Celsion Corporation
Published: 2004-07-19
License: https://open.fda.gov/license/

Celsion Corporation / initiated 2004-07-19 / Terminated / root cause: software

FDA source

Celsion Corporation began a recall of Prolieve Thermodilatation System, model number M0068808000, labeled in part***Distributed by Boston Scientific Corporation, Natick, MA Manufactured by Celsion... on 2004-07-19. The reason FDA records is "Software controlling a medical device for patient treatment may malfunction and cause thermal injury to patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1339-04
Status: Terminated
Initiated: 2004-07-19
Posted: 2004-08-11
Terminated: 2005-03-31
Recalling firm: Celsion Corporation
Product: Prolieve Thermodilatation System, model number M0068808000, labeled in part***Distributed by Boston Scientific Corporation, Natick, MA Manufactured by Celsion Corporation, Columbia, MD 21046***
Product code: MEQ System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
Reason for recall: Software controlling a medical device for patient treatment may malfunction and cause thermal injury to patient.
Root cause tag: software
FDA root cause: Other
Action: 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.
Quantity in commerce: 28 devices
Distribution: Devices were distributed to 19 medical facilities and physician end users nationwide by the recalling firm''s contract distributor.
Product codes and lots: CEL0204AK CEL0204BK CEL0204CK CEL0204DK CEL0204EK CEL0204FK CEL0204GK CEL0204HK CEL0204IK CEL0204JK CEL0604AK CEL0604BK CEL0604CK CEL0604DK CEL0604EK CEL0604FK CEL0604GK CEL0604HK CEL0604IK CEL0604JK CEL0604KK CEL0604LK CEL0604MK CEL0604NK CEL0604OK CEL0604PK CEL1904AK CEL1904BK

Product code MEQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)