iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion ce
Check against the official notice below — it lists the full affected range.
Optovue, Inc. is recalling 326 units of the iVue 500 with iScan, a high-resolution imaging device used for eye imaging procedures. The recall affects devices distributed nationwide across 38 states. The recall was initiated because the FDA determined that additional regulatory clearance (a 510(k) submission) is needed for the Vault Mapping software, also known as Lens Fitting, which is part of the device.
The affected devices include three catalog numbers: 700-49428-001, 700-49428-002 (GTIN 00858848006315), and 700-49428-003 (GTIN 00858848006018). The recall notice does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Reason for recall: FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). Distribution: US Nationwide Distribution in the states of - AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, & WV. Quantity: 326 devices Lot/code info: Cat No. 700-49428-001 (GTIN - N/A), 700-49428-002 (GTIN 00858848006315), 700-49428-003 (GTIN 00858848006018).
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.