Z-2245-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2020
- Initiation Date
- April 13, 2020
- Termination Date
- April 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1075 Units
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.
Distribution Pattern
US Nationwide distribution.
Code Information
Every lot distributed since 1996 with Part #94023