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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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).
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Philips North America, LLC
- Reason for Recall:
- The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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).
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2244-2020
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