Class II — Brainlab AG
| Recalling firm | Brainlab Ltd. |
|---|---|
| Registered facility | Brainlab Ltd. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery (IGS) Systems: DRMS spheres may separate at the mid-point where the two halves of the sphere are sealed together. |
| Product | Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system. They are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field. Radiology. |
| Quantity | For 28 US consignees, 9,900 Disposable reflective marker spheres ***For 451 non-US consignees, 359,280 Disposable reflective marker spheres |
| Distribution | Worldwide Distribution: US (nationwide) including states of: TX, CA, TN, NY, LA, IL, MA, PA, OH, AZ, ID, CT, MI, and KY; and countries of: Algeria, Argentina, Australia, Bahrain, Belarus, Bolivia, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Japan, K… |
| Initiated | 2015-08-18 |
| Classified | 2015-09-18 |
| Terminated | 2017-01-05 |
| Recall number | Z-2795-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Brainlab AG (Z-2795-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71996/
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