Philips Chest Pneumograph Recalled for Missing Latex Labeling
Philips is recalling Chest Pneumograph accessories because the labeling does not 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 labeling error regarding a common allergen (latex) without reported injuries or illnesses, fitting the 'Minor labeling errors' or 'voluntary precautionary' criteria for a Moderate severity score.
Plain-English summary
Philips North America, LLC is recalling 2,360 units of the Chest Pneumograph accessory for cardiovascular monitoring devices. The recall is due to a labeling deficiency: the product labeling does not include a statement indicating that the product contains natural rubber latex.
The affected accessory is used to monitor respiration by detecting abdominal or chest wall motion during MRI scans. It is indicated for use by healthcare professionals with the Wireless Sp02 (wSp02) Module or Toshiba KSB gating unit. The recall covers units distributed nationwide in the United States since 1996 with model/catalog number BSM43-0752-05.
Healthcare professionals should check their inventory for the affected model number and discontinue use if the product is intended for patients with latex allergies. The source text does not specify a specific action for consumers, as this is a professional medical device accessory.
The recalled product
- Product
- 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…
- Manufacturer
- Philips North America, LLC
- Affected units
- 2,360
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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