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 Pro

Is my product affected?

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

• UPC 04560141949492
• UPC 04560141949584

Check against the official notice below — it lists the full affected range.

What happened

Konica Minolta Healthcare Americas is recalling ImagePilot software versions 1.92 and 1.93 when paired with AeroDR or Momentum Panel systems. The software is used to process and display medical images on monitors for diagnostic purposes. The recall affects 30 units distributed nationwide. There is a potential risk that if an incorrect power sequence is followed, the software may produce incorrect length measurements or area calculations.

The recall involves specific serial numbers and UDI numbers for both software versions. The source document does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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 Distribution: US Nationwide distribution. Quantity: 30 units Lot/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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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