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

Recall Z-0874-2022 — Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Versio

U.S. FDA — Device Enforcement · United States · 2022-02-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0874-2022
Date of alert: 2022-02-02
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Philips North America Llc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00884838059030

Reported risk: Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from a different patient.

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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