Food, drugs, devices › Ziehm Imaging Inc
Device recall: Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
FDA enforcement event 66976 is a device recall by Ziehm Imaging Inc of Orlando, FL, initiated 21 Nov 2013 and classified Class II, with 7 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 23 Jun 2014. Initiation: voluntary: firm initiated. Ziehm Imaging Inc has 3 enforcement events on this register, with a median of 6 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Ziehm Imaging Inc, Orlando, FL.
Reason for recall
"Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices."
Distribution
"USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0562-2014 | Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging | 83 devices | Class II | Terminated | 1 Jan 2014 |
| Z-0563-2014 | Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging | 58 devices | Class II | Terminated | 1 Jan 2014 |
| Z-0564-2014 | Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging | 60 devices | Class II | Terminated | 1 Jan 2014 |
| Z-0565-2014 | Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging | 54 devices | Class II | Terminated | 1 Jan 2014 |
| Z-0566-2014 | Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging | 1 device | Class II | Terminated | 1 Jan 2014 |
| Z-0567-2014 | Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging | 103 devices | Class II | Terminated | 1 Jan 2014 |
| Z-0568-2014 | Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging | 27 devices | Class II | Terminated | 1 Jan 2014 |
Context
Other enforcement events for Ziehm Imaging Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 23 Feb 2017 | Ziehm Imaging solo FD Mobile Fluoroscopic C-arm | Device | Class II | 1 |
| 15 Apr 2016 | Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging | Device | Class II | 6 |
All 3 events for Ziehm Imaging Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 23 Jun 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.