# FDA recall Z-2245-2020

> **Philips North  America, LLC** · Class II · device recall initiated 2020-04-13.

## Product

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 accessory to a MRI patient monitoring system or MRI gating solution. The Chest Pneumograph is indicated for use by healthcare professionals with the Wireless Sp02 (wSp02) Module or Toshiba KSB gating unit when bellows-derived respiration sensing is needed during MRI scans for gating.

## Reason for recall

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

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2245-2020
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-13
- **Report date:** 2020-06-10
- **Termination date:** 2023-04-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2245-2020

## Citation

> AI Analytics. FDA recall Z-2245-2020. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-2245-2020. Source: US FDA. Licensed CC0.

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