RecallRadar

FDA Device recall Z-1864-2014

Ingenia 3.0T, magnetic resonance imaging system

On 2014-07-02 the FDA classified a Class II recall of Ingenia 3.0T, magnetic resonance imaging system by Philips Medical Systems, citing for some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1864-2014
ClassificationClass II
Statusterminated
Initiated2014-06-13
Published2014-07-02
Last updated2026-09-13 11:53 UTC
CompanyPhilips Medical Systems
DistributionUS

Product

Ingenia 3.0T, magnetic resonance imaging system.

Reason

For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.

Identifiers

code_infoModel Number: 781377

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1864-2014%22

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