iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digit
Check against the official notice below — it lists the full affected range.
Optovue, Inc. is recalling 326 iFusion iCam devices distributed nationwide across 38 states. The iCam is a non-contact, high resolution digital imaging device used for photographing, displaying, and storing images. The recall was initiated because the FDA determined that a 510(k) premarket notification is needed for the Vault Mapping software, also known as Lens Fitting, which is part of the device.
The affected devices include those with catalog numbers 700-49001-001, 700-49001-003, and 700-49001-004. The source does not specify what action affected consumers should take.
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. 700-49001-001 (GTIN - N/A), 700-49001-003 (GTIN - N/A), 700-49001-004 (GTIN 00858848006186).
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.