CLASS II ONGOING Device recall · Reported 20 Jul 2022 · FDA Enforcement Report
Philips Laser System recalled by Spectranetics
Spectranetics is recalling Philips Laser System, distributed in 23 states. The recall was initiated on 1 Jun 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1351-2022
- FDA event ID
- 90364
- Recalling firm
- Spectranetics, Colorado Springs, CO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Jun 2022
- FDA classified
- 11 Jul 2022
- Reported
- 20 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 1 Jun 2022 | Recall initiated by company | |
| 11 Jul 2022 | Classified by FDA | +40 days |
| 20 Jul 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM
Where it was distributed
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
ArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIllinoisKansasLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNew JerseyNew YorkPennsylvania
Questions about this recall
Is Philips Laser System recalled?
Yes. Spectranetics recalled Philips Laser System on 1 Jun 2022. The recall is Class II and its status is Ongoing. Recall number Z-1351-2022.
Why was it recalled?
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.
Which lots are affected?
Serial Numbers: 100000 to 100104 UDI/DI: (01)00813132027452
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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