Exact FDA event identifier

Event 74013

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

Event summary

Timeline bucket: April 15, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Ziehm Imaging 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

6 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 6

Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging

Z-2639-2016

Recall number: Z-2639-2016
Initiated: April 15, 2016
Classification: Class II
Status: Terminated
Recalling firm: Ziehm Imaging Inc
Quantity: 31 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

Code information

Serial #'s 20628, 20657, 20658, 20659, 20660, 20671, 20672, 20678, 20679, 20680, 20681, 20682, 20683, 20684, 20685, 20686, 20687, 20712, 10713, 20714, 20715, 20717, 20718, 20722, 20723, 20724, 20725, 20726, 20772, 20793, and 20794.

Distribution pattern

US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.

device · product 2 of 6

Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging

Z-2640-2016

Recall number: Z-2640-2016
Initiated: April 15, 2016
Classification: Class II
Status: Terminated
Recalling firm: Ziehm Imaging Inc
Quantity: 14 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

Code information

Serial #'s 20379, 20398, 20399, 20403, 20413, 20415, 20534, 20601, 20602, 20618, 20619, 20620, 20621, and 20720.

Distribution pattern

US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.

device · product 3 of 6

Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging

Z-2641-2016

Recall number: Z-2641-2016
Initiated: April 15, 2016
Classification: Class II
Status: Terminated
Recalling firm: Ziehm Imaging Inc
Quantity: 2 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

Code information

Serial #'s 20719 and 20721.

Distribution pattern

US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.

device · product 4 of 6

Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging

Z-2642-2016

Recall number: Z-2642-2016
Initiated: April 15, 2016
Classification: Class II
Status: Terminated
Recalling firm: Ziehm Imaging Inc
Quantity: 1 device

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

Code information

Serial # 10841.

Distribution pattern

US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.

device · product 5 of 6

Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging

Z-2643-2016

Recall number: Z-2643-2016
Initiated: April 15, 2016
Classification: Class II
Status: Terminated
Recalling firm: Ziehm Imaging Inc
Quantity: 12 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

Code information

Serial #'s: 51837. 51838, 51900, 51901, 51902, 51903, 51953, 51955, 51973, 51974, 51975 and 51977.

Distribution pattern

US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.

device · product 6 of 6

Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging

Z-2644-2016

Recall number: Z-2644-2016
Initiated: April 15, 2016
Classification: Class II
Status: Terminated
Recalling firm: Ziehm Imaging Inc
Quantity: 2 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

Code information

Serial #'s: 91760 and 91770.

Distribution pattern

US Distribution including Puerto Rico and to the states of :FL, GA, VA,MA. ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, and WA.