Elekta, Inc. recalls Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta Harmony; c. Elekta…
There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.
Read the official notice →- Date
- 2021-10-20
- Country
- United States
- Brand
- Elekta
- Product
- Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta Harmony; c. Elekta…
- Classification
- Class II
- Units
- Distributed nationwide to FL, NC, OH, CA, IL, MD, OR, AL, NY, PA, MA, AK, GA,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Elekta recalls
- 2023-06-07
USElekta, Inc. recalls Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
FDA · DeviceElekta, Inc.Worldwide distribution. US distribution to AR, IN, LA, OK, TN, VA, WA.…Official notice →- 2023-03-15
- US
Elekta Inc recalls Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
FDA · DeviceElekta IncNationwide distribution in the US. International distribution to Albania,…Official notice → - 2022-12-21
- US
Elekta, Inc. recalls Oncentra Brachy radiation therapy planning system software.
A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
FDA · DeviceElekta, Inc.Distribution US nationwide, including Puerto Rico. There was no…Official notice → - 2021-11-03
- US
Elekta, Inc. recalls Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
FDA · DeviceElekta, Inc.Distribution throughout USA OUS distribution including:Algeria, Argentina,…Official notice → - 2021-10-06
- US
Elekta, Inc. recalls MOSAIQ Oncology Information System
A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
FDA · DeviceElekta, Inc.Distribution was made to CA, CO, FL, ID, LA, MO, MS, NC, NH, NM, NV, NY, OH,…Official notice → - US
Elekta Inc recalls Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
FDA · DeviceElekta IncWorldwide distribution - US Nationwide distribution in the states of PA, MI,…Official notice →
Other drugs & medical recalls in the United States
- 2021-10-27
- US
- US
Beiersdorf Inc recalls Coppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC…
Chemical contamination; presence of benzene
- 2021-10-20
- US
Beckman Coulter Inc. recalls Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
Missing splash guard which may expose users to hazardous materials. .
FDA · DeviceBeckman Coulter Inc.U.S. Nationwide Distribution in the states of: CA, GA, IA, ID, IL, IN, LA, MA,…Official notice → - US
ELEKTA SOLUTIONS AB recalls Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.
FDA · DeviceELEKTA SOLUTIONS ABDistribution was to ND and NC. There was no military/government distribution.Official notice → - US
Flower Orthopedics Corporation recalls Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as…
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
FDA · DeviceFlower Orthopedics CorporationArizona California Colorado Florida Florida Illinois Indiana Nevada Ohio Texas…Official notice → - US
Uoc Usa Inc recalls United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025
Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.