Elekta Recalls DMLC IV-ERGO Beam Shaping Blocks for Radiation Therapy
Elekta, Inc. is recalling 31 DMLC IV-ERGO beam shaping blocks used in radiation therapy due to potential clinical mistreatment from workflow errors or incorrect settings.
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 involves a medical device where clinical mistreatment may occur, representing a risk-of-harm product where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Elekta, Inc. is recalling 31 units of the DMLC IV-ERGO beam shaping block for radiation therapy. The recall is issued because clinical mistreatment may occur when there are errors in the clinical workflow or when settings are incorrect.
The affected products were distributed nationwide to facilities in Alabama, Connecticut, Florida, Georgia, Iowa, Mississippi, Missouri, New Jersey, New York, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, Texas, Virginia, and Puerto Rico. Specific unit codes associated with this recall include EM-042, EM7-004, EM-046, EM-060, EM-047, EM-029, EM7-003, EM7-002, EM7-008, EM-062, EM-063, EM3-004, 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116068, 116013, and 116046.
Healthcare facilities should contact Elekta, Inc. for instructions on how to return or replace the affected devices. Patients who have received treatment with these devices should consult their healthcare provider if they have concerns regarding their treatment history.
The recalled product
- Product
- DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
- 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)
- EM-042
- EM7-004
- EM-046
- EM-060
- EM-047
- EM-029
- EM7-003
- EM7-002
- EM7-008
- EM-062
- EM-063
- EM3-004
- 116001
- 116012
- 116044
- 116055
- 116014
- 116052
- 116023
- 116056
Distribution
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