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

Recall Z-0931-2024 — BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161

U.S. FDA — Device Enforcement · United States · 2023-12-15 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0931-2024
Date of alert
2023-12-15
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Philips North America
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
453560462131
Reported risk: Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion, contusion, laceration, and/or fracture to the patient's lower limbs, as well as an interruption to normal system operation. If detector is positioned above center of gantry, there may be an interruption to normal system operation.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.