Philips Ingenuity Core MRI Scanner Recalled for Cover Crack Risk
Philips Medical Systems is recalling Ingenuity Core MRI scanners because a thinner plastic cover may crack, posing an injury risk to patients and staff.
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 risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling one unit of the Ingenuity Core MRI scanner, model # 728326. The device is intended to produce cross-sectional images of the body.
The recall was initiated because a supplier design change resulted in the use of thinner plastic for the device cover. This thinner plastic may crack, which could cause injury to patients, operators, by-standers, and service personnel.
The affected unit was distributed in China, Denmark, Germany, Hungary, Italy, the Philippines, Spain, Sweden, Switzerland, Thailand, and the United Kingdom. No specific instructions for consumers are provided in the source text, but the hazard involves potential physical injury from the cracking cover.
The recalled product
- Product
- Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — MRI Scanner
- Affected units
- 1
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)
- 901510
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Philips Medical Systems (Cleveland) Inc 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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