Food, drugs, devices › Maquet Cardiovascular Us Sales, Llc
Device recall: Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH &
FDA enforcement event 71446 is a device recall by Maquet Cardiovascular Us Sales, Llc of Wayne, NJ, initiated 10 Jun 2015 and classified Class II, with 1 product record.
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. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 18 Apr 2016. Initiation: voluntary: firm initiated. Maquet Cardiovascular Us Sales, Llc has 40 enforcement events on this register, with a median of 1 product record 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
Maquet Cardiovascular Us Sales, Llc, Wayne, NJ.
Reason for recall
"There is a potential issue that could result to collision between the C-arm of the angiography system and the MAGNUS OR table system. After switching on the angiography-system, in rare cases, MAGNUS column provides wrong position data for the longitudinal movement leading to a collision."
Distribution
"Worldwide Distribution - US Nationwide Distribution and to the countries of : France, Australia, Belgium, Brazil, Switzerland, Chile, China, Germany, Spain, United Kingdom, Hong Kong, Ireland,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2097-2015 | Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co. | 12 units | Class II | Terminated | 29 Jul 2015 |
Context
Other enforcement events for Maquet Cardiovascular Us Sales, Llc
All 40 events for Maquet Cardiovascular Us Sales, Llc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "There is a potential issue that could result to collision between the C-arm of the angiography system and the MAGNUS OR table system. After switching on the angiography-system, in rare cases, MAGNUS column provides wrong position data for the longitudinal movement leading to a collision."
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: "Worldwide Distribution - US Nationwide Distribution and to the countries of : France, Australia, Belgium, Brazil, Switzerland, Chile, China, Germany, Spain, United Kingdom, Hong Kong, Ireland,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Apr 2016. "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.