1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic… — Class II medical device recall Z-0811-2014
Terminated recall by Ziemer Usa Inc, reported 2014-01-29, distributed nationwide. A defect in the controller board can lead to the condenser to the video monitor becoming too warm. This could
| Recall number | Z-0811-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ziemer Usa Inc, Alton, IL, United States |
| Recall initiated | 2013-04-16 |
| Classified | 2014-01-23 |
| Reported by FDA | 2014-01-29 |
| Terminated | 2017-12-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, FI, JP |
| Quantity | 5 units |
| Serial numbers | FLM2963, FLM3281, FLM3817, FLM3907, FLM4135 |
Product
1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface. 2) The FEMTO LDV Z4 Femtosecond Surgical Laser is an opthalmic surgical laser indicated for use in the creation of the corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that does not enclose a volume of the cornea. 3) The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that may enclose a volume of the cornea.
Reason for recall
A defect in the controller board can lead to the condenser to the video monitor becoming too warm. This could potentially cause the video monitor to shut off.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0811-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.