Bausch & Lomb Stellaris PC Laser Recall for Software Anomaly
Bausch & Lomb is recalling 106 Stellaris PC laser systems because a software anomaly may cause the device to automatically transition from Standby to Ready to Fire during surgery.
What this means for you
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 surgical laser potentially firing unexpectedly, which poses a risk of harm to patients, but the source text does not report any specific injuries or fatalities.
Plain-English summary
Bausch & Lomb Incorporated is recalling 106 units of the Stellaris PC w/ Laser (model BL14304) due to a software anomaly. The issue involves the system potentially automatically transitioning from the "Standby" state to the "Ready to Fire" state while in surgical use.
The affected devices were distributed worldwide, including in the United States and various international markets. The recall covers specific serial numbers listed in the agency's documentation.
Healthcare providers should stop using the affected devices and contact Bausch & Lomb for further instructions on remediation or replacement.
The recalled product
- Product
- Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY
- Manufacturer
- Bausch & Lomb Inc
- Category
- Medical Device — Surgical Laser
- Affected units
- 106
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: SPC01790
- SPC01791
- SPC01792
- SPC01793
- SPC01794
- SPC01795
- SPC01796
- SPC01797
- SPC01798
- SPC01799
- SPC01800
- SPC01801
- SPC01802
- SPC01803
- SPC01806
- SPC01807
- SPC01808
- SPC01809
- SPC01810
- SPC01811
Distribution
Part of a larger recall action
This product is one of 3 recalled by Bausch & Lomb Inc 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.
See all 3 products in this recall →Related recalls
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