Bard EnCor EnCompass breast biopsy system recalled for probe calibration and pressure sensor errors
What this means
The EnCor EnCompass breast biopsy and tissue removal system console and driver may experience probe calibration failures or pressure sensor errors during use. When these errors occur, the system prompts the user to restart and recalibrate, which can interrupt the biopsy procedure, prolong it, or require additional tissue sampling or a repeat biopsy.
- Check if your system serial number matches the affected list provided by Bard.
- Contact Bard Peripheral Vascular Inc. for software updates or device service instructions.
- If errors occur during a procedure, follow the system prompts to restart and recalibrate before continuing.
The agency's original wording
Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to restart and re-calibrate; errors may lead to interruption or prolongation of the biopsy procedure, or the need for additional tissue sampling or repeat biopsy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3275-2026Want us to check the next one for you?
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