Recall Z-2795-2015 ยท HAW Neurological Stereotaxic Instrument
Brainlab AG
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 t
| Date | Aug 18, 2015 |
| 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. |
| Root cause | Process control |
| Action | The firm, Brainlab AG, sent out a" FIELD SAFETY NOTICE/ PRODUCT NOTIFICATION" dated 7/23/2015 to its customers. The firm sent this letter to mitigate the potential effects of the affected Disposable Reflective Marker Spheres (DRMS) when used with Brainlab Image Guided Surgery (IGS) systems. The firm advised the medical users that they should take the following steps prior to each procedure using Brainlab DRMS spheres for Brainlab IGS systems: -Prior to opening the package containing the spheres, visually inspect the spheres in the blister pack for any signs of separation between the two halv |
| Quantity | For 28 US consignees, 9,900 Disposable reflective marker spheres ***For 451 non-US consignees, 359,280 Disposable reflec |
| 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 Salvado |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100038 | DISPOSABLE REFLECTIVE MARKER SPHERES Brainlab AG, Jul 14, 2010 |