BC Group International Recalls Defibrillator and Pacer Analyzer Units
BC Group International is recalling five DA-2006P Defibrillator / Pacer Analyzer units because reversed wires cause inverted waveforms.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor functional issues without reported harm.
Plain-English summary
BC Group International Inc is recalling five units of the DA-2006P Defibrillator / Pacer Analyzer. The device is intended to measure the output of a defibrillator or transcutaneous pacemaker. The recall involves specific serial numbers: 73962222, 73962223, 73962224, 73962225, and 73962226.
The recall is due to a manufacturing defect where two wires running to the ECG distribution circuit board are reversed. This error results in inverted waveforms, meaning the device is not functioning as intended. The affected units were distributed in South Carolina, Florida, and Canada.
Users of these devices should stop using them and contact BC Group International Inc for further instructions. The U.S. Food and Drug Administration has classified this recall as Class III, indicating that the defect is unlikely to cause adverse health consequences.
The recalled product
- Product
- DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
- Manufacturer
- BC Group International Inc
- Hazard
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- SN: 73962222
- 73962223
- 73962224
- 73962225
- and 73962226
Distribution
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