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.
Read the official notice →- Date
- 2021-10-20
- Country
- United States
- Brand
- Elekta Solutions Ab
- Product
- Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
- Classification
- Class II
- Units
- Distribution was to ND and NC. There was no military/government distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Solutions Ab recalls
- 2025-11-26
USELEKTA SOLUTIONS AB recalls MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0…
When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule.
FDA · DeviceELEKTA SOLUTIONS ABWorldwide - U.S. Nationwide distribution in the state of NM and the countries…Official notice →
Other drugs & medical recalls in the United States
- 2021-10-27
- 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, 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.
FDA · DeviceElekta, Inc.Distributed nationwide to FL, NC, OH, CA, IL, MD, OR, AL, NY, PA, MA, AK, GA,…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.
- US
Draeger Medical, Inc. recalls Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up…
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds