Liebel-Flarsheim Hydra Vision DR 60/80 System Recalled for High Dosage
Liebel-Flarsheim is recalling 12 Hydra Vision DR 60/80 systems because a service call found the maximum fluoroscopy dose was three times the safety limit.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states that the dosage was three times the safety limit, which constitutes a significant risk of harm.
Plain-English summary
Liebel-Flarsheim Company LLC is recalling 12 units of the Hydra Vision DR 60/80 System, Models 700539 and 700540. These systems are used in radiologic imaging procedures. The affected units were distributed nationwide, including in Tennessee, Kentucky, Colorado, Kansas, Connecticut, Hawaii, and Arizona.
The recall was initiated after a hospital physicist reported that the dosage on the system was too high. During a subsequent service call, technicians discovered that the system's Maximum Fluoro Dose was set to 30 R/min. This level is three times the established Maximum Fluoro Dose limit of 10 R/min.
The recall covers specific catalog and serial numbers manufactured between 2003 and 2011. Healthcare facilities should contact Liebel-Flarsheim Company LLC to arrange for the correction of the dosage settings on the affected equipment.
The recalled product
- Product
- Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
- Manufacturer
- Leibel-Flarsheim Company LLC
- Hazard
- Affected units
- 12
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 (12)
- The following catalog numbers
- 700539 CI0106H162 January 2006
- 700539 CI1010H523 October 2010
- 700539 CI0811H567 August 2011
- 700539 CI0108H313 January 2008
- 700539 CI0309H418 March 2009
- 700539 15031229 Apri12003
- 700539 14031227 Apri12003
- 700539 CI0404H045 January 2005
- 700539 CI0504H054 May 2004
- 700539 CI1106H208 November 2006
- 700539 CI0509H424 May 2009
Distribution
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