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LINET spol. s r.o.

Slany, CZ

LINET spol. s r.o. appears in FDA device records in Slany, CZ. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
0
PMA records
0
Recall records
3
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to LINET spol. s r.o. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Linet Spol. S.r.o.enforcement report, recall

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

FDA registered establishments for LINET spol. s r.o., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30080582313008058231LINET spol. s r.o.Zelevcice 5, Slany Stredocesky Kraj 27401 CZ2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1211-2023Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1.Labeling being updated to assure user is securing the siderail to a locked position to prevent potential patient fall and injury.Class IIOpen, Classified
Z-0767-2021Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45, c) 1GE512055-85, and d) 1GE512055-95 - Product Usage: Eleganza 5 is a positionable bed for intensive care. Its purpose is to support patient and to facilitate treatment and manipulation with patient for nursing personnel.A component used within the side rail mechanism may malfunction, resulting in the side rail either not locking properly in the upper position or the side rail becoming stuck in the upper position.Class IIOpen, Classified
Z-0991-2019AVE 2 Birthing BedLINET has recently become aware of a potential safety issue for the AVE 2 Birthing Bed caused by the power cable breaking at the bed connection or the orange insulation of the power cable may fail causing a possible spark or possible exposure to a live conductor.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain