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Philips Medical Systems DMC GmbH Recall 90490

Description: DigitalDiagnost 4 High Performance. radiography and fluoroscopy system

Philips Medical Systems DMC GmbH Recall 90490 Information

StatusOngoing
Mandated?FDA Mandated
Recall NumberZ-1326-2022
Event ID90490
Event DescriptionDigitalDiagnost 4 High Performance. radiography and fluoroscopy system
Product TypeDevices
DistributionUS Nationwide Distribution
Quantity120 systems in total
Recall ReasonFollowing a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy.
Device Classification20220720
Device Code InfoModel 712031 Serial Numbers - 10001009 10001111 18000123 19000181 20010235 10001039 17000264 18000263 19000297
Center Classification Date20220712
Recall Initiation Date20210519
Recalling FirmPhilips Medical Systems DMC GmbH
Initial Notification Letter
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