Philips Chest Pneumograph Recalled for Missing Natural Rubber Latex Labeling
Philips is recalling 1,075 Chest Pneumograph units because the labeling fails to state that the product contains natural rubber latex.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a minor labeling error regarding a known allergen (natural rubber latex) with no reported illnesses or injuries, fitting the criteria for a moderate severity recall.
Plain-English summary
Philips North America, LLC is recalling 1,075 units of the Chest Pneumograph, an accessory used with MRI diagnostic devices to monitor respiration. The recall is due to a labeling defect: the product labeling does not include a statement indicating that the product contains natural rubber latex.
The affected units were distributed nationwide in the United States. The recall covers every lot distributed since 1996 with Part #94023. The Chest Pneumograph is indicated for use by healthcare professionals with specific MRI gating solutions when bellows-derived respiration sensing is needed.
Healthcare professionals and consumers should check their devices for Part #94023. If the device is affected, they should stop using it and contact Philips North America, LLC for instructions on how to proceed.
The recalled product
- 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…
- Manufacturer
- Philips North America, LLC
- Category
- Medical Device — MRI Accessory
- Affected units
- 1,075
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Every lot distributed since 1996 with Part #94023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Philips North America, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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