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

Recall Z-2110-2016 — Big Bore Radiology tomography X-ray system scanner, model number 728244. The Big Bore Radiology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes

U.S. FDA — Device Enforcement · United States · 2016-06-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2110-2016
Date of alert: 2016-06-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Philips Medical Systems (Cleveland) Inc
Product category: device
Product type: Devices

Reported risk: Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainless steel rather than the specified alloy steel.

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.

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