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

Recall Z-0970-2013 — CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the image plate, once exposed, is inserted in the Agfa Digitizer CR 10-X where the image plate is taken ou

U.S. FDA — Device Enforcement · United States · 2013-02-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0970-2013
Date of alert: 2013-02-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: AGFA Corp.
Product category: device
Product type: Devices

Reported risk: The cassettes were shipped with the wrong IP (image plate) size bar code.

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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