Z-0713-05

Bloom DTU-215-B Programmable Stimulator

Name: Z-0713-05 Bloom DTU-215-B Programmable Stimulator
Creator: Fischer Imaging Corporation
Published: 2005-01-13
License: https://open.fda.gov/license/

Fischer Imaging Corp. / initiated 2005-01-13 / Terminated

FDA source

Fischer Imaging Corporation began a recall of Bloom DTU-215-B Programmable Stimulator on 2005-01-13. The reason FDA records is "Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0713-05
Status: Terminated
Initiated: 2005-01-13
Posted: 2005-04-19
Terminated: 2012-03-13
Recalling firm: Fischer Imaging Corp.
Product: Bloom DTU-215-B Programmable Stimulator
Product code: JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Reason for recall: Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients.
FDA root cause: Other
Action: Customers were notified by letter on 01/13/05.
Quantity in commerce: 712 units
Distribution: Nationwide. Foreign distribution: Canada, Australia, Ireland, Italy, Japan, Malaysia, Switzerland, Netherlands, United Kingdom.
Product codes and lots: All Bloom DTU-215-B Programmable Stimulators.

Product code JOQ

K991293Class IIEpstim Electrophysiology Stimulator Control Program, Bloom Dtu-215 Electrophysiology Programmable StimulatorFischer Medical Technologies, Inc. / cleared 2000-05-05

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)