Recall Z-1612-2015— Fujifilm Medical Systems U.S.A., Inc.
Class II · Terminated
Class II FDA medical device recall by Fujifilm Medical Systems U.S.A., Inc., initiated 2015-02-04, terminated 2018-09-20. It names one FDA 510(k) clearance: K023112. Product: Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Picture Archiving and Communication System Computer, Diagnostic, Programmable. Reason: Under certain circumstances the patient Demographics in a report exported into the EMR may not match the demographics shown in the corresponding Synapse CV clinical report..
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-02-04
- Terminated
- 2018-09-20
- Firm location
- Stamford, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Picture Archiving and Communication System Computer, Diagnostic, Programmable
Reason for recall
Under certain circumstances the patient Demographics in a report exported into the EMR may not match the demographics shown in the corresponding Synapse CV clinical report.
Data sourced from openFDA. This site is unofficial and independent of the FDA.