Philips NMT Patient Cable Recall for Potential Skin Burn Risk
Philips is recalling NMT Patient Cables used with IntelliVue NMT Modules because a manufacturing defect may cause localized heating and skin burns.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that may cause skin burns (risk-of-harm product), but the source text does not report any confirmed injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Electronics North America Corporation is recalling 9,120 NMT Patient Cables (Part # 989803174581) used with IntelliVue NMT Modules (Part # 865383). The recall is due to a manufacturing defect that may cause localized heating, which may result in localized skin burns.
The affected devices were distributed in 31 US states and numerous countries outside the United States. The source text does not specify the exact number of reported injuries or illnesses associated with this defect.
Healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice. If a device is affected, it should be removed from service and returned to Philips for repair or replacement according to the company's instructions.
The recalled product
- Product
- NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)
- Manufacturer
- Philips Electronics North America Corporation
- Affected units
- 9,120
Distribution
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