CLASS II Device recall · Reported 24 Jan 2018 · FDA Enforcement Report

Aspire Cristalle (FDR MS-3500) Mammography machine recalled

Fujifilm Medical Systems U is recalling Aspire Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography. The recall was initiated on 14 Jul 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesFDR MS-3500 : S/N- 76221095 or earlier

Quantity recalled15 US 1 OUS

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0386-2018
FDA event ID: 78891
Recalling firm: Fujifilm Medical Systems U, Stamford, CT
Classification: Class II
Status: Terminated
Recall initiated: 14 Jul 2017
FDA classified: 18 Jan 2018
Reported: 24 Jan 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

14 Jul 2017	Recall initiated by company
18 Jan 2018	Classified by FDA	+188 days
24 Jan 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There was a case that the swivel arm went down unintentionally when it was moved up/down.

Product as listed by the FDA

ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.

Where it was distributed

US Distribution and Internationally to Mexico.

Questions about this recall

Why was it recalled?

There was a case that the swivel arm went down unintentionally when it was moved up/down.

Which lots are affected?

FDR MS-3500 : S/N- 76221095 or earlier

Where was it sold?

US Distribution and Internationally to Mexico.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 78891

Reported	Class	Recall	Company	Reason	Where
24 Jan 2018	CLASS II	Aspire HD Plus (FDR MS-2500) recalled by Fujifilm Medical Systems U.S.A	Fujifilm Medical Systems U	Other	CT

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