Elekta Precise Treatment Table Recalled for Positioning Error Risk
Elekta is recalling Precise Treatment Tables because incorrect sensor installation during maintenance can cause undetected positioning errors, potentially leading to clinical mistreatment.
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 risk of clinical mistreatment due to undetected positioning errors, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Elekta, Inc. is recalling the Elekta Precise Treatment Table. The recall is due to a potential issue where the treatment table may be positioned with errors greater than 5mm without displaying any inhibits or warnings. This can occur if the positional sensors are not correctly installed during corrective maintenance.
If a position error is not detected, clinical mistreatment may occur. The source text does not specify the number of units affected, specific dates, or reported injuries.
Healthcare facilities should contact Elekta for instructions on how to address this issue. Consumers and patients should consult their healthcare providers for guidance regarding their specific treatment equipment.
The recalled product
- Product
- Elekta Precise Treatment Table
- Manufacturer
- Elekta, Inc.
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 (18)
- Precise Treatment Table Serial Numbers: (124001-125803
- 125807-880
- 125883-899
- 125902-917
- 125920-949
- 125952-963
- 125966-1256453
- 126158-170
- 126174-208
- 126212-230
- 126232-261
- 126269-281
- 126293-309
- 123318-330
- 126338-126373
- 126375-397
- 126400-133999
- 213000+)
Distribution
Distributed nationwide across the United States.
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