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Terminated

Bloom DTU-215-B Programmable Stimulator

FDA Recall Z-0713-05 · Posted 2005-04-19

Recalling FirmFischer Imaging Corporation
Recall StatusTerminated
Product CodeJOQ
Date Initiated2005-01-13
Date Terminated2012-03-13
Product Quantity712 units

Reason for Recall

Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients.

Firm Action

Customers were notified by letter on 01/13/05.

Root Cause

Other

Distribution Pattern

Nationwide. Foreign distribution: Canada, Australia, Ireland, Italy, Japan, Malaysia, Switzerland, Netherlands, United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991293EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATORFischer Medical Technologies, Inc. · 2000-05-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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