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FDA (Device enforcement)Recalled 2025-04-22class ii

C-RAD POSITIONING AB: Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Cat

Hazard

Software issue with scanning equipment that can results in the filed rotation not being applied correctly.

Details from the source

Reason for recall: Software issue with scanning equipment that can results in the filed rotation not being applied correctly. Distribution: Worldwide - US Nationwide distribution in the states of AK, FL, WA, VA, WA, NC, IL, AR, NC and the countries of Germany, Italy, Uzbekistan, South Korea, Vietnam, Austria, Australia, China, Estonia, Belgium, Uzbekistan. Quantity: 44 units Lot/code info: All Catalyst products using software Version: c4D 6.5.1 SP2 Catalyst -SP001-0025/UDI: 07350005280024; Catalyst HD- SP001-0026/UDI: 07350005280024; Catalyst PT- SP001-0027/UDI: 07350005280024; Catalyst X4- SP002-0035/UDI: 07350005280024; Catalyst+ - REF: SP003-0001/UDI: 17350005280762 Catalyst+ HD- SP003-0002/UDI: 17350005280779 Catalyst+ PT- SP003-0008/UDI: 17350005280793 Catalyst+ X4 - SP003-0009/UDI: 17350005280809

UPC codes

07350005280024, 17350005280762, 17350005280779, 17350005280793, 17350005280809

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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