Magnetic Resonance Imaging Diagnostic Device accessory — Class II medical device recall Z-2245-2020
Terminated recall by Philips North America, LLC, reported 2020-06-10, distributed nationwide. The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contain
| Recall number | Z-2245-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America, LLC, Andover, MA, United States |
| Recall initiated | 2020-04-13 |
| Classified | 2020-06-02 |
| Reported by FDA | 2020-06-10 |
| Terminated | 2023-04-14 |
| Distributed | Nationwide (US) |
| Quantity | 1,075 units |
| Reason classes | labeling |
| Model numbers | 94023 |
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.
Reason for recall
The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2245-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.