GE Healthcare Recalls Disposable Temperature Probes Due to Safety Concerns
GE Healthcare is recalling disposable temperature probes due to a potential safety issue with esophageal placement.
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 is classified as FDA Class II, and the source text describes a 'potential safety issue' regarding probe insertion without reporting specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
GE Healthcare is recalling its General Purpose 9 French Temperature Probe, Disposable, 400 Series (Product Number M1024229). The recall involves 12,239 units distributed worldwide, including the United States and various international markets.
The recall was initiated because GE Healthcare became aware of a potential safety issue associated with the use of the probes. Specifically, the company noted that some users are inserting the probe in a manner that raises safety concerns regarding esophageal placement. The probes are intended for oro-esophageal and rectal use for continuous temperature monitoring.
Healthcare facilities and users who have purchased these specific probes should stop using them and contact GE Healthcare for instructions on how to return or dispose of the product. The recall covers units distributed in the US and countries including Australia, Belgium, Canada, and others.
The recalled product
- Product
- Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.
- Manufacturer
- Vital Signs Devices, a GE Healthcare Company
- Hazard
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)
- GE product number M1024229
Distribution
Distributed nationwide across the United States.
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