The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2114-2016·Announced 2016-07-06

Philips Ingenuity Core 128 MRI Systems Recalled for Cover Crack Risk

Philips is recalling 14 Ingenuity Core 128 MRI systems 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 risk of injury to patients and personnel due to a structural defect (cracking plastic), which aligns with the 'Severe' criteria for significant injury reports or structural defects.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 14 units of the Ingenuity Core 128 MRI system, model #728323. These devices are intended to produce cross-sectional images of the body. The recall involves specific serial codes: 901469, 901479, 901487, 901491, 901497, 901502, 901508, 901515, 901517, 901518, 901520, 901530, 901533, and 921223.

The recall was initiated because a supplier design change resulted in the use of thinner plastic for the device covers. 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. The source text does not specify actions for consumers or patients, as these are medical devices used in clinical settings.

The recalled product

Product
Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — MRI System
Hazard
Affected units
14

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 (14)

  • 901469
  • 901479
  • 901487
  • 901491
  • 901497
  • 901502
  • 901508
  • 901515
  • 901517
  • 901518
  • 901520
  • 901530
  • 901533
  • 921223

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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