FDA Enforcement
Class II
Terminated
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: Z-0500-2022
·
Reported January 26, 2022
Enforcement
- Recall Number
- Z-0500-2022
- Event ID
- 89275
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Konica Minolta Healthcare Americas, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 26, 2022
- Initiation Date
- December 3, 2021
- Classification Date
- January 14, 2022
- Termination Date
- January 5, 2024
- Address
- 411 Newark Pompton Tpke, N/A, Wayne, NJ, 07470-6657, United States
Description
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
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
Code Info
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
Distribution
US Nationwide distribution.
Quantity
30 units