Stephanix D2RS Digital Dynamic Remote System Recalled for Table Movement Risk
Stephanix is recalling 17 D2RS Digital Dynamic Remote Systems because the table may continue moving after a command is released.
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 is classified as FDA Class II. The hazard involves a mechanical failure where the table may continue moving, posing a risk of harm (injury) to patients or staff, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Stephanix is recalling 17 units of the D2RS Digital Dynamic Remote System. This medical device is indicated for generating fluoroscopic images of human anatomy for vascular angiography, diagnostic, and interventional procedures, as well as cardiology procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology and is not intended for mammography applications.
The recall was initiated because the firm detected a potential risk associated with using the command. Specifically, after releasing the command, the movement of the table may continue instead of stopping. This issue poses a risk of injury to patients or operators if the table does not stop as expected.
The affected units were distributed nationwide in the United States, specifically in the states of FL, IN, WV, TN, MO, WI, CA, GA, and PA. The specific serial codes for the affected units are DHJ008, DIG010, DIH012, DIH014, DIK022, DIK024, DIL025, DIL030, DJK051, DJK052, DKI032, DKI033, DKJ047, DKK051, DKK052, DLA001, and DML062. Users should contact Stephanix for instructions on how to resolve this issue.
The recalled product
- Product
- STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional…
- Manufacturer
- Stephanix
- Affected units
- 17
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 (17)
- DHJ008
- DIG010
- DIH012
- DIH014
- DIK022
- DIK024
- DIL025
- DIL030
- DJK051
- DJK052
- DKI032
- DKI033
- DKJ047
- DKK051
- DKK052
- DLA001
- DML062
Distribution
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