Elekta Integrity 3.0 Multileaf Collimator Recalled for Beam Delivery Tolerance Issues
Elekta, Inc. is recalling Integrity 3.0 multileaf collimators because incorrect static tolerances may prevent the detection of unexpected movement during radiation beam delivery.
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 where a failure to detect unexpected movement during radiation delivery poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Elekta, Inc. is recalling 31 units of the Integrity 3.0 multileaf collimator. This device is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed. The recall is due to a software issue where incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0 may prevent the detection of unexpected movement during beam delivery.
The affected units were distributed nationwide in the United States, including California, Florida, Illinois, Maryland, Massachusetts, New Jersey, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, the District of Columbia, and Puerto Rico. Specific serial numbers for the affected units are listed in the agency's recall record.
Healthcare providers and facilities using these devices should contact Elekta, Inc. for instructions on how to address the issue. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.
- Manufacturer
- Elekta, Inc.
- Affected units
- 31
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)
- 325134
- 325254
- 325082
- 325159
- 325268
- 325237
- 325331
- 325267
- 325236
- 325314
- 325127
- 325261
- 325286
- 325077
- 325269
- 325129
- 325296
- 325273
- 325139
- 325201
Distribution
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Similar recalls
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