Elekta Precise Treatment Table Recalled for Column Rotation Defect
Elekta, Inc. is recalling 443 Precise Treatment Tables because the column rotation can accidentally move from its locked position during radiation therapy.
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 involves a medical device used in radiation therapy where a mechanical failure could lead to patient injury, but no injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Elekta, Inc. is recalling 443 units of the Precise Treatment Table, a device used as part of the radiation therapy treatment process. The recall is due to a defect where the column rotation can accidentally be moved to a different position while in the locked position.
The affected units were distributed nationwide and in Puerto Rico. The recall covers specific serial numbers listed in the official FDA record. No injuries or illnesses have been reported in the source text.
Consumers and healthcare facilities should contact Elekta, Inc. for instructions on how to resolve the issue. The device should be used with caution or removed from service until the defect is addressed to ensure patient safety during radiation therapy.
The recalled product
- Product
- Precise Treatment Table. To be used as part of radiation therapy treatment process.
- Manufacturer
- Elekta, Inc.
- Affected units
- 443
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)
- 151855
- 151611
- 152008
- 151587. 151694
- 152019
- 105864
- 105932
- 151574
- 151267
- 152397
- 152248
- 152559
- 151875
- 151965
- 151369
- 152502
- 105829
- 152262
- 151504
- 151159
Distribution
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