Atom Medical Infant Incubator Model 100 Recalled for Canopy Movement
Atom Medical Corporation is recalling 377 Dual Incu i infant incubators because the canopy may move unintentionally during use.
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 for infants with a mechanical defect that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Atom Medical Corporation is recalling 377 units of the Dual Incu i (Atom Infant Incubator Model 100). The recall was initiated because there is a potential for the device's canopy to move unintentionally when the incubator is used in either incubator mode or radiant warmer mode.
The affected units were distributed worldwide, including in the United States (specifically Pennsylvania) and numerous international locations such as Japan, Kuwait, Saudi Arabia, Italy, Spain, China, and Germany. The recall covers all lots of Model 100 currently on the market.
Consumers and healthcare facilities should stop using the affected incubators and contact Atom Medical Corporation for further instructions on how to proceed with the recall.
The recalled product
- Product
- Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
- Manufacturer
- Atom Medical Corporation
- Affected units
- 377
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)
- All lots on the market of model 100
Distribution
Distributed in 1 state:
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