The Recall Desk
ModerateFDA (Devices)·Z-1865-2014·Announced 2014-07-02

Philips Recalls Ingenia MRI Systems Due to Incorrect Nut Material

Philips is recalling 24 Ingenia 1.5T MRI systems because some units shipped between December 2013 and March 2014 were supplied with incorrect M10 nuts instead of A4 stainless steel nuts.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any injuries, illnesses, or specific safety hazards resulting from the incorrect nut material, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Philips Medical Systems, Inc. is recalling 24 Ingenia 1.5T magnetic resonance imaging systems. The recall affects specific units shipped between December 2013 and March 2014.

The recall was initiated because cover set rear magnetic M10 nuts were erroneously supplied instead of the required A4 stainless steel nuts. This defect involves the material composition of the hardware used in the system's cover set.

The affected systems were distributed worldwide, including in the United States and numerous international markets. The source text does not specify instructions for consumers or healthcare providers regarding immediate action, but the recall is managed by the recalling firm, Philips Medical Systems, Inc.

The recalled product

Product
Ingenia 1.5T, magnetic resonance imaging system.
Affected units
24

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)

  • Model Number: 781396

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Philips Medical Systems, 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 4 products in this recall →