CLASS II Device recall · Reported 10 Jun 2020 · FDA Enforcement Report

Magnetic Resonance Imaging Diagnostic Device accessory recalled

Philips North America is recalling Magnetic Resonance Imaging Diagnostic Device accessory, distributed nationwide in the US. The recall was initiated on 13 Apr 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesEvery lot distributed since 1996 with Part #94023

Quantity recalled1075 Units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2245-2020
FDA event ID: 85560
Recalling firm: Philips North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 13 Apr 2020
FDA classified: 2 Jun 2020
Reported: 10 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Imaging Equipment

Timeline

13 Apr 2020	Recall initiated by company
2 Jun 2020	Classified by FDA	+50 days
10 Jun 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Magnetic Resonance Imaging Diagnostic Device accessory recalled?

Yes. Philips North America recalled Magnetic Resonance Imaging Diagnostic Device accessory on 13 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-2245-2020.

Why was it recalled?

The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.

Which lots are affected?

Every lot distributed since 1996 with Part #94023

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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