Med Tec recalls Solstice Tilting Head Fixation System (part numbers CHS03/CHS04) due to potential movement during patient setup or treatment. Affected units include specific lot numbers and UDI codes.
There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.
Med Tec is recalling its Solstice Tilting Head Fixation System (part numbers CHS03 and CHS04) because it may move during patient setup or treatment. This could lead to improper patient immobilization, potentially causing injury.
The Solstice Tilting Head Fixation System may move during patient setup or treatment due to the way the bowl attaches to the baseplate. This movement could cause the patient to be immobilized less precisely than intended, increasing the risk of injury during radiation treatments.
Healthcare providers using the Solstice Tilting Head Fixation System for patient immobilization are most at risk. Patients receiving treatment with this system may be affected if the device moves during setup.
Check for part numbers CHS03 or CHS04 on the device. Affected units have specific lot numbers (M602380, M680480, M847590, M870360 for CHS03) or (M680530, M789100, M789110, M839690, M938500 for CHS04).
Identify part numbers CHS03 or CHS04 on the Solstice Tilting Head Fixation System.
The Solstice Tilting Head Fixation System may move during patient setup or treatment, which could lead to improper patient immobilization and potential injury.
For part number CHS03: lot numbers M602380, M680480, M847590, M870360. For part number CHS04: lot numbers M680530, M789100, M789110, M839690, M938500.
No, but you should check if your device is affected and follow the action steps to ensure safety.
We’ve drafted a message you can send Med Tec to request your refund or repair — edit it as you like.
Subject: Recall Z-1837-2019 — Med Tec Med Tec Hello, I own a Med Tec that is covered by recall Z-1837-2019 from Med Tec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.