FDA Medical Device Recalls (openFDA)
BC Group International Inc: DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
- Recall number
- Z-0457-2016
- Recalling firm
- BC Group International Inc
- Product
- DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
- Status
- Terminated
- Initiated
- 2015-10-28
- Posted
- 2015-12-22
- Terminated
- 2017-02-15
- Reason
- Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.
- Root cause
- Employee error
- Action
- The recalling firm issued return authorization numbers to the two customers who submitted complaints regarding the malfunctioning device. The customers sent back the units and the recalling firm replaced their devices with new units. On 10/29/2015, the recalling firm contacted their third customer by phone and informed them that the three devices they had in their possession were miswired which would cause the inverted ECG waveform. The recalling firm issued a return authorization number to their customer for the three devices. The recalling firm told their customer they would repair the devices and return them.
- Quantity
- 5 units
- Distribution
- US Nationwide Distribution in the states of South Carolina, Florida, and Canada.
- Lot, serial or model codes
- SN: 73962222, 73962223, 73962224, 73962225, and 73962226
- 510(k) numbers
- ["K110192"]
- PMA numbers
- not on file
- Product code
- DRL
- Firm FEI
- 2939012
- Firm city
- Saint Charles
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28