Philips Ingenuity Flex MRI Units Recalled for Cracking Cover Hazard
Philips is recalling 10 Ingenuity Flex MRI units 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (cracking plastic) that poses a risk of injury to patients and personnel, meeting the criteria for a Severe rating.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 10 units of the Ingenuity Flex MRI system, model # 728317. The device is intended to produce cross-sectional images of the body. The recall involves specific serial codes: 901475, 901476, 901495, 901505, 901509, 901513, 901529, 901532, 901539, and 901541.
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 units were distributed in China, Denmark, Germany, Hungary, Italy, the Philippines, Spain, Sweden, Switzerland, Thailand, and the United Kingdom.
Healthcare facilities and service personnel should contact Philips Medical Systems for instructions on how to address the defect. The source text does not specify a particular action for consumers other than the general risk to individuals in the vicinity of the device.
The recalled product
- Product
- Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — MRI System
- Affected units
- 10
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 (10)
- 901475
- 901476
- 901495
- 901505
- 901509
- 901513
- 901529
- 901532
- 901539
- 901541
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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