The Recall Desk
SevereFDA (Devices)·Z-2113-2016·Announced 2016-07-06

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Hazard
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.

See all 5 products in this recall →

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