The Recall Desk

Manufacturer

SIE AG, Surgical Instrument Engineering

1 recall in our database name SIE AG, Surgical Instrument Engineering as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2018-04-04

Of the 1 recalls from SIE AG, Surgical Instrument Engineering we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • ModerateFDA (Devices)·Z-1272-2018·2018-04-04

    SIE AG Recalls FEMTO LDV Z8 Femtosecond Surgical Lasers

    SIE AG is recalling 125 FEMTO LDV Z8 femtosecond surgical lasers worldwide due to usability and performance improvements identified after a cataract procedure complication.

    Product
    The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rin
    Category
    Medical Device
    Distribution
    Distributed nationwide