Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1441-2020 — SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 - Product Usage: Soundwave 3.2 is used by healthcare professionals to program Advanced Bionics sound processors for use with Advanced Bionics coch

U.S. FDA — Device Enforcement · United States · 2019-04-04 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1441-2020
Date of alert: 2019-04-04
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Advanced Bionics, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 07630016853227

Reported risk: The manufacturer received complaints that customers were attempting to install the fitting software using the supplied USB drive, an error message was received, and installation failed. The failed installation has not impact to the current version of the software, and users are able to continue programming devices with the current software version.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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