CLASS II ONGOING Device recall · Reported 27 Jan 2021 · FDA Enforcement Report

Synapse PACS recalled by Fujifilm Medical Systems U.S.A

Fujifilm Medical Systems U is recalling Synapse PACS, distributed nationwide in the US. The recall was initiated on 11 Sep 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware Versions 5.1, 5.2, 5.3, 5.4, 5.5, and 5.7.

Quantity recalled235

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-0878-2021
FDA event ID: 86532
Recalling firm: Fujifilm Medical Systems U, Lexington, MA
Classification: Class II
Status: Ongoing
Recall initiated: 11 Sep 2020
FDA classified: 16 Jan 2021
Reported: 27 Jan 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

11 Sep 2020	Recall initiated by company
16 Jan 2021	Classified by FDA	+127 days
27 Jan 2021	Published in enforcement report	+11 days

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

Reason for recall

There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Synapse PACS Software Versions 5.1 and higher

Where it was distributed

Software was distributed to medical facilities nationwide throughout the U.S.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Software Versions 5.1, 5.2, 5.3, 5.4, 5.5, and 5.7.

Where was it sold?

Software was distributed to medical facilities nationwide throughout the U.S.

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.

More recalls from Fujifilm Medical Systems U

All 37

Reported	Class	Recall	Company	Reason	Where
9 Jun 2021Device	CLASS II	Synapse Cardiovascular (Synapse CV) recalled	Fujifilm Medical Systems U	Device Malfunction	Nationwide
21 Apr 2021Device	CLASS II	¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit recalled	Fujifilm Medical Systems U	Device Malfunction	6 states
14 Apr 2021Device	CLASS II	Synapse PACS - Radiological Image Processing System recalled	Fujifilm Medical Systems U	Device Malfunction	Nationwide
3 Feb 2021Device	CLASS II	Fujifilm Synapse Pacs recalled by Fujifilm Medical Systems U.S.A	Fujifilm Medical Systems U	Device Malfunction	Nationwide
3 Feb 2021Device	CLASS III	Wako Hdl-c/Ldl-c Calibrator recalled by Fujifilm Medical Systems U.S.A	Fujifilm Medical Systems U	Other	Nationwide

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9 Sep 2026Device	CLASS II	Philips Ingenuity CT recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Brilliance CT 64: Brilliance CT 64 Channel recalled	Philips North America	Device Malfunction	MA
8 Sep 2026Device	ANNOUNCED	BMC Luna G3 APAP recalled by BMC MedicalBMC	BMC Medical	Device Malfunction	Nationwide