The Recall Desk
ModerateFDA (Devices)·Z-1864-2014·Announced 2014-07-02

Philips Ingenia 3.0T MRI Systems Recalled for Incorrect Hardware

Philips is recalling 18 Ingenia 3.0T MRI systems because incorrect M10 nuts were used instead of 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. The hazard involves incorrect hardware (nuts) rather than a direct biological or electrical safety failure, and no injuries or illnesses are reported in the source text.

Plain-English summary

Philips Medical Systems, Inc. is recalling 18 Ingenia 3.0T magnetic resonance imaging systems. The recall was initiated because cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts on some systems shipped between December 2013 and March 2014.

The affected units were distributed nationwide in the United States, including in Alabama, Arizona, California, Colorado, Georgia, Maine, Michigan, New York, Ohio, Pennsylvania, Texas, and Washington. The systems were also distributed in numerous countries worldwide, including Mexico, Argentina, Australia, and the United Kingdom.

Healthcare facilities should contact Philips Medical Systems for instructions on how to replace the incorrect hardware. The recall is classified as Class II by the FDA.

The recalled product

Product
Ingenia 3.0T, magnetic resonance imaging system.
Manufacturer
Philips Medical Systems, Inc.
Category
Medical Device — Imaging Equipment
Hazard
Affected units
18

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: 781377

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 →

Related recalls

Same manufacturer · Philips Medical Systems, Inc.

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