Swissray Medical Recalls ddR Formula B X-ray Systems for Bucky Movement Risk
Swissray Medical is recalling 27 ddR Formula B X-ray systems because the bucky component may move unexpectedly, posing a risk of injury to patients.
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 risk-of-harm product (unexpected movement of a medical device component) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Swissray Medical is recalling 27 units of the ddR Formula B X-ray System in the United States. The recall is due to a potential defect where the bucky, the moveable part that holds the grid and positions the patient, may move unexpectedly.
The affected devices are distributed nationwide in the US and in several other countries, including Austria, Dubai, China, Germany, Libya, Malaysia, Russia, and South Africa. The recall covers specific serial numbers listed in the agency's records.
Healthcare facilities should stop using the affected X-ray systems and contact Swissray Medical for instructions on corrective action. Patients who have used these devices should consult their healthcare provider if they experience any related issues.
The recalled product
- Product
- ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
- Manufacturer
- Swissray Medical
- Affected units
- 27
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 (20)
- Serial Numbers within U.S.A commerce - 1302002
- 1302003
- 1302005
- 1302009
- 1302011
- 1402001
- 1402002
- 1402006
- 1402007
- 1402008
- 1402009
- 1402011
- 1402012
- 1402015
- 1502001
- 1502002
- 1502004
- 1502005
- 1502006
- 1502007
Distribution
Distributed nationwide across the United States.
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