Medical Device Recall: LFS Flat Screen Support Arm Bracket Failure
The FDA is recalling LFS flat screen support arm systems because the stopper block could be broken or missing. Without this stopper, the screen can rotate excessively and damage the bracket's spring shaft.
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: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard is mechanical—a faulty stopper block could cause the bracket's spring shaft to break—but the risk is theoretical and undocumented.
Plain-English summary
The FDA is recalling LFS flat screen support arm systems for surgical use, affecting multiple Aurora series models (Aurora, Aurora 2, Aurora 3, Aurora 4, Aurora Astro), Stellar XL, and Stellar series. A total of 1,211 units are being recalled.
The defect involves the stopper block on the LFS bracket, which may be broken or missing. The stopper block limits how far the attached flat screen can rotate. Without a functioning stopper block, the screen can rotate beyond its original safe angle limit. This excessive rotation places significant force on the spring shaft of the LFS bracket, potentially causing the spring shaft to break and shear off.
The affected units were distributed in Michigan.
The recalled product
- Product
- LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro series, Stellar XL, and Stellar series, LFS Flat Screen Support Arm Model Numbers
- Manufacturer
- DKK Dai-Ichi Shomei Co., Ltd.
- Affected units
- 1,211
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: RA000006
- RA000007
- RA000008
- RA000009
- RA000010
- RA000244
- RA000245
- RA000246
- RA000247
- RA000248
- RA000359
- RA000360
- RA000361
- RA000362
- RA000363
- RA000364
- RA000365
- RA000366
- RA000367
- RA000368
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by DKK Dai-Ichi Shomei Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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