CombiDiagnost R90 1.0 (709030)
Check against the official notice below — it lists the full affected range.
Philips Medical Systems is recalling 86 units of the CombiDiagnost R90 1.0 fluoroscopy imaging system due to a software issue where the Radio Fluoroscopy viewer may display a previous patient's radiography images during an examination. When this occurs, the displayed images differ in content, format, and size from the current examination images. The affected devices are distributed nationwide across 16 states and are identified by specific serial numbers with software version 1.1.1 or higher.
The recall notice does not specify a remedy for affected consumers or healthcare facilities.
Written by software from the official notice below. Not reviewed by a lawyer.
While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.
Reason for recall: While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size. Distribution: US Nationwide distribution in the states of CA, FL, GA, IL, IN, KS, MD, ME, MI, MN, NC, NJ, NY, TX, VA, WA. Quantity: 86 units Lot/code info: Model: R90 1.0 (709030); UDI DI: 00884838076747; Software version 1.1.1 or higher; Serial numbers: 10000000, 10000002, 10000003, 10000004, 10000006, 10000011, 10000012, 10000020, 10000024, 10000027, 10000049, 10000050, 10000065, 10000066, 10000067, 10000069, 10000078, 10000081, 10000099, 10000103, 10000107, 10000140, 10000145, 10000152, 10000180, 10001001, 10001010, 10001095, 591362, SN16000009, SN17000003, SN17000007, SN17000015, SN17000022, SN17000111, SN17000114, SN17000118, SN17000120, SN17000121, SN17000122, SN17000123, SN17000128, SN17000129, SN17000130, SN17000145, SN17000146, SN17000147, SN17000148, SN17000153, SN17000157, SN17000163, SN17000165, SN17000166, SN18000003, SN18000004, SN18000010, SN18000021, SN18000025, SN18000033, SN18000037, SN18000038, SN18000044, SN18000045, SN18000053, SN18000054, SN18000057, SN18000060, SN18000068, SN18000069, SN18000079, SN19000004, SN19000006, SN19000011, SN19000020, SN19000034, SN19000036, 27, 40, 41, 42, 77, 101, 131, 155, 180, 190;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.