Elekta Solutions Ab FDA Recalls

2 recalls on file across devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3Class IISep 17, 2025When appending a care plan that contains one or more wave me	When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of	Class IIDevices	Sep 17, 2025
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta VClass IISep 28, 2021There is a risk that the Diode D1 in the Modulator can fail	There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the mach	Class IIDevices	Sep 28, 2021