Device 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.
Z-2245-2020
Product summary
- Event
- Event 85560
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1075 Units
- Official record key
device-enforcement:Z-2245-2020
Official wording
Reason: The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.
Code information: Every lot distributed since 1996 with Part #94023
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.