IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
Check against the official notice below — it lists the full affected range.
Medical Intelligence Medizintechnik GmbH is recalling iGuide System software versions 2.2.0, 2.2.1, and 2.2.2, which are used to control patient positioning during linear accelerator radiation therapy. The problem is that the Constant Correlation Check (CCC) sensitivity setting can sometimes be too sensitive and incorrectly demand a verification scan even after the HexaPOD positioning system has reached its target position. Approximately 496 units worldwide have been distributed with this affected software.
The affected devices are installed on various linear accelerator models including VERSA HD, ELEKTA INFINITY, ELEKTA SYNERGY, and ELEKTA AXESSE units. The source document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (CCC) can be too sensitive and iGUIDE may incorrectly demand a verification scan.
Reason for recall: Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (CCC) can be too sensitive and iGUIDE may incorrectly demand a verification scan. Distribution: Worldwide Distribution - US Nationwide Quantity: 496 units Lot/code info: UDI (GTIN) iGuide 2.2.0 = 04056719001704 iGuide 2.2.1 = 04056719001742 iGuide 2.2.2 = 04056719002039 Installed on the following units: Master Devices with serial numbers: VERSA HD/30002624-003/154166 VERSA HD/30000782-003/153788 VERSA HD/30000782-003/153788 VERSA HD/30000782-003/153788 ELEKTA INFINITY/19175-003/154363 VERSA HD/30001056-002/109016 VERSA HD/30001009-001/153427 ELEKTA INFINITY/11766-003/152570 VERSA HD/11766-004/153649 ELEKTA SYNERGY/11766-002/151717 VERSA HD/17114-001/153383 VERSA HD/19677-005/109018 VERSA HD/30003910-LIN001/109005 VERSA HD/30003903-LIN001/109006 VERSA HD/30003903-LIN002/109035 VERSA HD/30001230-003/153428 VERSA HD/15081-LIN003/109003 ELEKTA SYNERGY/15081-002/152131 VERSA HD/12486-003/109036 VERSA HD/15240-003/109033 ELEKTA SYNERGY/15240-001/152128 ELEKTA SYNERGY/15240-002/152419 ELEKTA SYNERGY/20967-001/153012 VERSA HD/30003249-001/154299 VERSA HD/14756-002/153003 ELEKTA SYNERGY/14756-001/151916 ELEKTA SYNERGY/12579-003/152379 ELEKTA AXESSE/18225-001/152691 VERSA HD/18225-003/153900 VERSA HD/30001349-001/154087 VERSA HD/20965-001/153008 VERSA HD/30002428-LIN001/154024 ELEKTA AXESSE/11654-003/152617 VERSA HD/11654-006/109013 VERSA HD/10394-AKHEE/153248 VERSA HD/12570-#001/154395 VERSA HD/12570-#002/154435 VERSA HD/12490-KLG02E/154043 VERSA HD/12490-KLG04/153699 VERSA HD/17152-#001/156066 ELEKTA SYNERGY/10266-IBK02E/152807 VERSA HD/10266-IBK05/153055 VERSA HD/10266-IBK01E/154680 ELEKTA SYNERGY/10266-IBK04/151431 VERSA HD/11517-C8230/154221 VERSA
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.