Food, drugs, devices › FUJIFILM Healthcare Americas Corporation
Device recall: Synapse PACS - Version 7.1.000
FDA enforcement event 94090 is a device recall by FUJIFILM Healthcare Americas Corporation of Lexington, MA, initiated 10 Jan 2024 and classified Class II, with 6 product records.
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. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. FUJIFILM Healthcare Americas Corporation has 14 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 Healthcare Americas Corporation, Lexington, MA.
Reason for recall
"Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements."
Distribution
"Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, Namibia, Netherlands,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1268-2024 | Synapse PACS - Version 7.1.000 | 22 units (22 OUS) | Class II | Ongoing | 13 Mar 2024 |
| Z-1269-2024 | Synapse PACS - Version 7.1.000US | 3 Units (3 US) | Class II | Ongoing | 13 Mar 2024 |
| Z-1270-2024 | Synapse PACS - Version 7.2.000 | 19 Units (7 US, 12 OUS) | Class II | Ongoing | 13 Mar 2024 |
| Z-1271-2024 | Synapse PACS - Version 7.2.100 | 35 Units (28 US, 7 OUS) | Class II | Ongoing | 13 Mar 2024 |
| Z-1272-2024 | Synapse PACS - Version 7.2.200 | 12 Units (12 US) | Class II | Ongoing | 13 Mar 2024 |
| Z-1273-2024 | Synapse PACS - Version 7.3.000 | 64 Units (44 US, 20 OUS) | Class II | Ongoing | 13 Mar 2024 |
Context
Other enforcement events for FUJIFILM Healthcare Americas Corporation
All 14 events for FUJIFILM Healthcare Americas Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements."
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, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, Namibia, Netherlands,…"
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.