Z-0500-2022Class II

ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical...

Name: Z-0500-2022 ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical...
Creator: Konica Minolta Healthcare Americas, Inc.
Published: 2021-12-03
License: https://open.fda.gov/license/

Konica Minolta, Inc. / initiated 2021-12-03 / Terminated

FDA source

Konica Minolta Healthcare Americas, Inc. began a recall of ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics... on 2021-12-03. FDA classified it as Class II and gives the reason as "lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incorrect length measurement/area calculation if incorrect power sequence is followed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0500-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-03
Posted: 2022-01-14
Terminated: 2024-01-05
Recalling firm: Konica Minolta, Inc.
Product: ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC
Product code: LLZ System, Image Processing, Radiological
Reason for recall: lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incorrect length measurement/area calculation if incorrect power sequence is followed
FDA root cause: Under Investigation by firm
Action: Konica Minolta issued Urgent: Medical Device Recall lmagePilot Versions 1.92 and 1.93 Letter to Dealers on 12/8/21 and Customers on 12/15/21 via Fed'X. Letter states reason for recall, health risk and action to take: To ensure the correct sampling pitch is obtained from the AeroDR or Momentum panel, please refer to the enclosed "lmagePilot & AeroDR Start-up Sequence and Notice before Shutting Down lmagePilot." Konica Minolta has issued a countermeasure to minimize the risk of a potential incident. This corrective action can only be carried out on site by a Konica Minolta trained representative. Konica Minolta Healthcare or Business Partner will contact each site to schedule a visit. A Konica Minolta Representative will be contacting you within 30 days to schedule a visit. The dispatched representative will perform a check and repair process and alert the customer if any repair was needed to any of the images on the lmagePilot server. If image repair is needed, we recommend the images that were previously sent to PACS, NAS or burned to media be exported again. Questions contact your Konica Minolta representative or the Konica Minolta 24-hour Technical Support Department at 1-800-945-0456.
Quantity in commerce: 30 units
Distribution: US Nationwide distribution.
Product codes and lots: Software Versions 1.92 and 1.93 Serial Numbers: 996TDF3 F6H9BZ2 1MRNVD3 1MMCVD3 8WD00C3 GQT78B3 GQT68B3 1KMHK93 GSFH2G3 2UA5112C16 2UA5122N7T 1MMDVD3 5YZ0N83 1KNCK93 DHPJ8B3 GRF9673 8WDWZB3 1KMCK93 1KN6K93 1KNGK93 1KNDK93 GQP58B3 DHQN8B3 1KN8K93 1MSNVD3 G3M7773 9VQZ1G3 9VP02G3 5QQWR33 1KMFK93 UDI Number: V1.92: 04560141949492 V1.93: 04560141949584

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0500-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0500-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-26	2022-01-14

Product code LLZ

K210066Class IIImagePilotKonica Minolta, Inc. / cleared 2021-05-06

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)