CIVCO Solstice SRS Immobilization System Recalled for Potential Movement
Med Tec Inc is recalling 28 units of the CIVCO Solstice SRS Immobilization System because the device may move during patient setup or treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 with a risk of harm (movement during treatment) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Med Tec Inc is recalling 28 units of the CIVCO Solstice SRS Immobilization System, specifically part numbers CHS03 and CHS04. The affected devices are used to immobilize patients during radiation therapy or simulation. The recall is due to a potential for the Solstice Tilting Head Fixation System to move during patient setup and/or treatment.
The affected units were distributed worldwide, including in the United States (California, Hawaii, Pennsylvania, Kentucky, Florida, Wisconsin, and Alaska) and in Australia, Canada, Italy, the Netherlands, Switzerland, and Peru. Specific lot numbers for part number CHS03 include M602380, M680480, M847590, and M870360. Specific lot numbers for part number CHS04 include M680530, M789100, M789110, M839690, and M938500.
Healthcare providers and facilities should contact Med Tec Inc for instructions on how to handle the affected devices. Patients who have used these devices should consult their healthcare provider if they have concerns about their treatment.
The recalled product
- Product
- CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product Usage: The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and the locking level allows…
- Manufacturer
- Med Tec Inc
- Affected units
- 28
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 (10)
- Part Numbers: a) CHS03
- UDI 00841439112489 Lot Numbers: M602380
- M680480
- M847590
- M870360 b) CHS04
- UDI 00841439112496 Lot Numbers: M680530
- M789100
- M789110
- M839690
- M938500
Distribution
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