Z-2235-2023Class II

vRad PACS with Mammography

Name: Z-2235-2023 vRad PACS with Mammography
Creator: Virtual Radiologic Corp.
Published: 2023-05-09
License: https://open.fda.gov/license/

Virtual Radiologic Corporation / initiated 2023-05-09 / Open, Classified / root cause: software

FDA source

Virtual Radiologic Corp. began a recall of vRad PACS with Mammography on 2023-05-09. FDA classified it as Class II and gives the reason as "The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2235-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-09
Posted: 2023-07-21
Recalling firm: Virtual Radiologic Corporation
Product: vRad PACS with Mammography
Product code: LLZ System, Image Processing, Radiological
Reason for recall: The error resulted in intermittent failure of current (primary) radiology study images not displaying to the interpreting teleradiologist.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: The firm issued an URGENT FIELD CORRECION notice to its consignees beginning on 06/28/2023 via email. The notice explained the issue, root cause, and repair of the software. It was recommended that those consignees who experienced the malfunction review the affected cases.
Quantity in commerce: 8 units
Distribution: US Nationwide distribution in the states of MD, MN, TN, FL, GA, TX, OK.
Product codes and lots: (01)00862234000313(10)23.2 Build 23.2.0.117 through (01)00862234000313(10) 23.4 Build 23.4.25.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2235-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2235-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-21

Product code LLZ

K162145Class IIvRad PACS with MammographyVirtual Radiologic Corporation / cleared 2016-10-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)