FDA recall Z-2244-2020

Philips North America, LLC · Class II · device

Product

Cardiovascular Monitoring 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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2244-2020