Elekta Synergy XVI Radiation Therapy Imager Recalled for DICOM Tag Defect
Elekta, Inc. is recalling 164 Synergy XVI Radiation Therapy Digital Imagers because DICOM tags lack sufficient information to identify volumes with the same name.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (radiation therapy imager) where the defect could impact treatment accuracy, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Elekta, Inc. is recalling 164 units of the Synergy XVI Radiation Therapy Digital Imager, specifically software versions R3.5.1, R4.2.1, and R4.5.1. The recall is due to a defect where the DICOM tags do not contain sufficient information for the XVI system to identify different volumes that share the same name.
The affected devices were distributed nationwide, including the District of Columbia, Puerto Rico, and 37 states. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare facilities using these devices should contact Elekta, Inc. for further instructions on how to resolve the issue.
The recalled product
- Product
- Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
- Manufacturer
- Elekta, Inc.
- Affected units
- 164
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 151055
- 151700
- 151809
- 151695
- 151479
- 151696
- 151867
- 151704
- 151765
- 151860
- 151024
- 151521
- 151803
- 152217
- 151774
- 152220
- 151626
- 151842
- 151847
- 151446
Distribution
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