PlainRecalls
FDA Devices Moderate Class II Terminated

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 whe

Reported: June 10, 2020 Initiated: April 13, 2020 #Z-2245-2020

Product Description

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.

Details

Units Affected
1075 Units
Distribution
US Nationwide distribution.
Location
Andover, MA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Philips North America, LLC. Units affected: 1075 Units.
Why was this product recalled? ▼
The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 10, 2020. Severity: Moderate. Recall number: Z-2245-2020.

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