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.
Enforcement
- Recall Number
- Z-2244-2020
- Event ID
- 85560
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips North America, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 10, 2020
- Initiation Date
- April 13, 2020
- Classification Date
- June 2, 2020
- Termination Date
- April 14, 2023
- Address
- 3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States
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.
The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.
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).
US Nationwide distribution.
2360 Units