AMS GreenLight HPS and XPS Surgical Lasers Recalled for Electrical Non-Conformance
AMS Innovative Center is recalling 389 GreenLight HPS and XPS surgical laser systems because the Voltage Scaling Board failed to meet IEC 60601-1-2 electrical safety standards.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a technical non-conformance to an electrical standard, which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
AMS Innovative Center is recalling 389 units of the GreenLight HPS (High Performance System) and GreenLight XPS (Xcelerated Performance System) surgical laser systems. These devices are intended for use in endoscopic 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasia. The recall covers all model numbers, with specific part numbers ranging from 0010-0070 to 0010-0077 for HPS and 0010-0210 for XPS.
The recall was initiated after electrical recertification testing revealed that the Voltage Scaling Board in these devices was non-conforming to the IEC 60601-1-2 standard. This standard governs electromagnetic compatibility for medical electrical equipment. The affected devices were distributed worldwide.
Healthcare facilities and users should stop using the affected devices immediately and contact AMS Innovative Center for instructions on repair or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation Center. GreenLight HPS and XPS Surgical Lasers Systems and accessories are intended for use in endoscopic 532 nm laser resection of…
- Manufacturer
- AMS Innovative Center - San Jose
- Category
- Medical Device — Surgical Laser
- Affected units
- 389
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 (1)
- HPS Part numbers: 0010-0070 to 0010-0077
Distribution
Distribution scope not specified by the agency.
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