Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Summary
The FDA issued a Class II for Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3 by FujiFilm Healthcare Americas Corporation. Reason: Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not displa.
Details
Source
Device Recall
External ID
Z-0189-2022
Action Date
2021-11-10
Status
Ongoing
Category
device
Product Description
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Lot/Code Info: Serial Numbers: G3075073 (01)04562122959841(11)201214(21)G3075073; G3110777 (01)04562122959841(11)210421(21)G3110777; G3110771 (01)04562122959841(11)210421(21)G3110771; G3113780 (01)04562122959841(11)210510(21)G3113780; G3113778 (01)04562122959841(11)210510(21)G3113778; G3113779 (01)04562122959841(11)210510(21)G3113779; G3113777 (01)04562122959841(11)210510(21)G3113777; G3071857 (01)04562122959841(11)210420(21)G3071857; G3108384 (01)04562122959841(11)210402(21)G3108384; G3114220 (01)04562122959841(11)210510(21)G3114220; G3110776 (01)04562122959841(11)210421(21)G3110776; G3108385 (01)04562122959841(11)210402(21)G3108385; G3114223 (01)04562122959841(11)210518(21)G3114223; G3108401 (01)04562122959841(11)210420(21)G3108401; G3114959 (01)04562122959841(11)210524(21)G3114959
Quantity Affected: 15 units
Reason for Recall
Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-14
Company
Twinsburg, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 120 device recalls issued in the same week, part of 403 device-related FDA actions this month.
FujiFilm Healthcare Americas Corporation has 36 FDA actions in our database, including 23 recalls and 13 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (FujiFilm Healthcare Americas Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does FujiFilm Healthcare Americas Corporation have FDA actions?
FujiFilm Healthcare Americas Corporation has 36 FDA actions in our database, including 23 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0189-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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