Z-2244-2020 Class II Terminated
FDA device recall Z-2244-2020 was initiated by Philips North America, LLC on April 13, 2020 and is designated Class II. Reason for recall: The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex. The recall status is terminated (terminated April 14, 2023). Affected quantity: 2360 Units.
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
- 2360 Units
Product Description
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 Pattern
US Nationwide distribution.
Code Information
Every lot distributed since 1996 with model/catalog number: BSM43-0752-05 (Part number 0600-1005 is on the device label, but 0600-1005 is the non-sellable part of the sellable Toshiba part number BSM43-0752-05).