FDA Medical Device Recalls (openFDA)
Konica Minolta Healthcare Americas, Inc.: 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
- Recall number
- Z-0500-2022
- Recalling firm
- Konica Minolta Healthcare Americas, 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
- Status
- Terminated
- Initiated
- 2021-12-03
- Posted
- not on file
- Terminated
- 2024-01-05
- Reason
- 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
- 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
- 30 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K210066"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 2241281
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28