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June 29, 2023
Company: Philips North America Llc Date of Enforcement Report: 06/29/2023 Class II PRODUCT DigitalDiagnost C90, Model No. 712034 and 712035 Recall Number: Z-2042-2023 REASON: There is a software login in issue that may prevent the user from logging in. RECALLING FIRM/MANUFACTURER: Philips North America Llc VOLUME OF PRODUCT IN COMMERCE: 58 DISTRIBUTION: Distribution in US:...
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Company: Appliedvr Date of Enforcement Report: 06/29/2023 Class II PRODUCT RelieVR REF: RVX-2002, Rx Only Recall Number: Z-2044-2023 REASON: There is the potential for the program software to malfunction which will not allow it to move forward to the next session. RECALLING FIRM/MANUFACTURER: Appliedvr VOLUME OF PRODUCT IN COMMERCE: 1 unit DISTRIBUTION: US: NY OUS:...
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Upcoming Public Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

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