DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcuta
FDA device recall Z-0457-2016 · posted 2015-12-22 · Terminated
Recall details
- Recalling firm
- BC Group International Inc
- Reason for recall
- Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DRL
- Quantity affected
- 5 units
- Distribution
- US Nationwide Distribution in the states of South Carolina, Florida, and Canada.
- Date initiated
- 2015-10-28
- Date posted
- 2015-12-22
- Date terminated
- 2017-02-15
- Location
- Saint Charles, MO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DEFIBRILLATOR ANALYZER - DA-2006P (K110192) | Bc Group International, Inc. | 2011-02-08 |