Elekta Recalls Stereotactic Circular Collimators Due to Potential Clinical Errors
Elekta, Inc. is recalling 89 Stereotactic Circular Collimators used in radiotherapy for head tumors due to a potential for clinical errors.
What this means for you
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 (radiotherapy equipment) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Elekta, Inc. is recalling 89 units of the Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories. These devices are part of a class of medical equipment used in radiotherapy for the treatment of head tumors.
The recall was initiated due to a potential for clinical errors. The source text does not specify the nature of the error or report any specific injuries or illnesses associated with the use of these devices.
The affected units were distributed nationwide in the United States, including the states of Arizona, California, Florida, Georgia, Missouri, New Jersey, New Mexico, North Carolina, Oregon, Tennessee, and West Virginia. The specific unit codes affected are listed in the recall documentation. Healthcare facilities and users of these devices should contact Elekta, Inc. for further instructions on how to proceed.
The recalled product
- Product
- Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.
- Manufacturer
- Elekta, Inc.
- Hazard
- Affected units
- 89
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)
- 933
- 935
- 936
- 937
- 940
- 843
- 844
- 845
- 846
- 847
- 833
- 834
- 835
- 836
- 837
- 801
- 802
- 803
- 804
- 805
Distribution
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