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

Recall Z-2245-2020 — Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest pneumograph is an accessor

U.S. FDA — Device Enforcement · United States · 2020-04-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2245-2020
Date of alert: 2020-04-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Philips North America, LLC
Product category: device
Product type: Devices

Reported risk: The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.

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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