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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95709

7 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 08, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Orthoscan, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

7 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 7

Ziehm Solo. Digital Mobile C-arm

Z-0573-2025
Recall number
Z-0573-2025
Initiated
August 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Orthoscan, Inc.
Quantity
28

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

Code information

UDI: EZIEZIEHSOLO1. Serial Numbers: 50652, 51087, 51265, 52387, 52889, 53255, 54259, 54820, 54821, 54823, 54824, 54825, 54826, 55053, 55066, 55073, 55074, 55075, 55076, 55145, 55219, 55220, 55221, 55222, 55223, 55224, 55225, 55226.

Distribution pattern

U.S. (including Puerto Rico).

device · product 2 of 7

Ziehm Solo FD. Interventional fluoroscopic x-ray system

Z-0574-2025
Recall number
Z-0574-2025
Initiated
August 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Orthoscan, Inc.
Quantity
25

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

Code information

UDI: EZIEZIEHMSOLOFD1 Serial Numbers: 54301, 54772, 54773, 54774, 54792, 54793, 54794, 54795, 54796, 54797, 54798, 54851, 54852, 54855, 55020, 55021, 55114, 55115, 55116, 55117, 55118, 55119, 55120, 55121, 55212.

Distribution pattern

U.S. (including Puerto Rico).

device · product 3 of 7

Ziehm Vision system, x-ray, tomography, computed.

Z-0575-2025
Recall number
Z-0575-2025
Initiated
August 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Orthoscan, Inc.
Quantity
3

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

Code information

UDI: EZIEZIEHMVISIONFD1 Serial Numbers: 9246, 90155, 90416.

Distribution pattern

U.S. (including Puerto Rico).

device · product 4 of 7

Ziehm Vision FD. Interventional fluoroscopic x-ray system

Z-0576-2025
Recall number
Z-0576-2025
Initiated
August 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Orthoscan, Inc.
Quantity
22

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

Code information

UDI: EZIEZIEHMVISIONFD1651 Serial Numbers: 93412, 93443, 93451, 93452, 93461, 93483, 93485, 93486, 93503, 93619, 93620, 93621. 93622 93623 93628 93629 93660 93661 93662 93626 93625 93627

Distribution pattern

U.S. (including Puerto Rico).

device · product 5 of 7

Ziehm Vision R. Iterventional fluoroscopic x-ray system

Z-0577-2025
Recall number
Z-0577-2025
Initiated
August 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Orthoscan, Inc.
Quantity
5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

Code information

UDI: EZIEZIEHMVISIONR1. Serial Numbers: 10295, 10490, 10656, 10716, 10997.

Distribution pattern

U.S. (including Puerto Rico).

device · product 6 of 7

Ziehm Vision RFD. Interventional fluoroscopic x-ray system

Z-0578-2025
Recall number
Z-0578-2025
Initiated
August 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Orthoscan, Inc.
Quantity
30

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

Code information

UDI: EZIEZIEHMVISIONRFD1. Serial Numbers: 20048, 20240, 23805, 21350, 23249, 23250, 23251, 23252, 23253, 23324, 23375, 23376, 23377, 23378, 23379, 23380, 23381, 23382, 23412, 23452, 23460, 23461, 23462, 23463, 23506, 23536, 23721, 23737, 23738, 23739.

Distribution pattern

U.S. (including Puerto Rico).

device · product 7 of 7

Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system

Z-0579-2025
Recall number
Z-0579-2025
Initiated
August 08, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Orthoscan, Inc.
Quantity
50

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when being exposed to mechanical stress such as shocks (e.g. dropping) or impacts can irreversibly damage the switching element in the hand switch. A defective switching element may then potentially initiate unintended radiation of the connected mobile X-ray unit.

Code information

UDI: EZIEZIEHMVISIONRFD3D1. Serial Numbers: 21118, 21212, 22040, 22710, 22764, 23247, 23248, 23255, 23257, 23258, 23259, 23260, 23327, 23328, 23329, 23456, 23457, 23458, 23459, 23653, 23654, 23655, 23656, 23657, 23666, 23667, 23668, 23669, 23670, 23671, 23672, 23673, 23674, 23723, 23740, 23744, 23745, 23746, 23747, 23748, 23749, 23750, 23751, 23752, 23753, 23775, 23801, 23802, 23828, 23849.

Distribution pattern

U.S. (including Puerto Rico).