Food, drugs, devices › Fujifilm Medical Systems U.S.A., Inc.
Device recall: Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an
FDA enforcement event 87579 is a device recall by Fujifilm Medical Systems U.S.A., Inc. of Lexington, MA, initiated 2 Mar 2021 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Fujifilm Medical Systems U.S.A., Inc. has 27 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Fujifilm Medical Systems U.S.A., Inc., Lexington, MA.
Reason for recall
"The wrong patient information may be displayed in the viewer or PowerJacket."
Distribution
"Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1348-2021 | Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server). | 839 systems | Class II | Ongoing | 14 Apr 2021 |
Context
Other enforcement events for Fujifilm Medical Systems U.S.A., Inc.
All 27 events for Fujifilm Medical Systems U.S.A., Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The wrong patient information may be displayed in the viewer or PowerJacket."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.