Z-1351-2022Class II

Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240...

Name: Z-1351-2022 Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240...
Creator: Spectranetics Corporation
Published: 2022-06-01
License: https://open.fda.gov/license/

Spectranetics Corp. / initiated 2022-06-01 / Open, Classified / root cause: design

FDA source

Spectranetics Corporation began a recall of Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM on 2022-06-01. FDA classified it as Class II and gives the reason as "The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an error code and the system not being operable until code is cleared". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1351-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-01
Posted: 2022-07-11
Recalling firm: Spectranetics Corp.
Product: Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
Product code: LPC Device, Angioplasty, Laser, Coronary
Reason for recall: The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an error code and the system not being operable until code is cleared.
Root cause tag: design
FDA root cause: Device Design
Action: On June 08, 2022 Spectranetics issued a "Urgent Medical Device Correction" notification to affected consignees via USPS. The recall notification asked consignees to take the following actions: 1. Philips internal testing confirms that 1-3 reboots of the system will temporarily resolve the issue. Philips also recommends the continued use of the Philips Laser System, and to follow the Operator s Manual, as there is no expected harm to the user or patient. Philips recommends notifying all Philips Laser System users within your facility of this communication and retain a copy of this letter for reference. To acknowledge receipt of this notification, please complete, sign, and return the Customer Reply Form, included with this letter, within 30 days upon receipt of this notice to the following Email: [email protected] If you are a distributor or have forwarded affected device(s) to another end user, it is imperative that all end-users with affected devices receive this URGENT Medical Device Correction. Therefore, send a copy of this notification to any customer to whom you have distributed the affected product. If you need any further information or support concerning this issue, please contact your local Philips representative or Philips IGTD Customer Service: Philips Laser System (PLS) Customer Service: Phone: 1-800-231-0978 Email: [email protected] Hours of Operation: Monday - Friday 9:00AM 5:00PM MST
Quantity in commerce: 105 units
Distribution: US: AR AZ CA CO CT FL GA HI IA IL IN KS LA MA MD ME MI MN MO NC NJ NY OK PA TN TX VA OUS: Saudi Arabia, Denmark, France, Greece, India, Italy, Netherlands, Serbia, Spain, Sweden, United Kingdom
Product codes and lots: Serial Numbers: 100000 to 100104 UDI/DI: (01)00813132027452

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1351-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1351-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-20	2022-07-11

Product code LPC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)