510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2283-2013Class II

The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote...

Stryker Medical / initiated 2013-08-19 / Terminated / root cause: design

Stryker Medical Division of Stryker Corporation began a recall of The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes. It can... on . FDA classified it as Class II and gives the reason as "The nurse call cable (Part Number: QDF23-0571) on the FL23SE Bed is located right under the opening of the bed head box. If an accessory (i.e. IV pole) is inserted into this slot, the circuit directing the nurse call...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2283-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Medical
Product
The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes. It can be operated by the patient or the caregiver to adjust the height and surface contour of the bed. The bed includes movable and latchable siderails. The FL23SE Bed is intended for use with patients for procedures, therapy, recovery in healthcare environments, and to transport patients between bays and procedural rooms. The FL23SE Bed is intended for use with patients for procedures, therapy, recovery in healthcare environments, and to transport patients between bays and procedural rooms.
Product code
FNL Bed, Ac-Powered Adjustable Hospital
Reason for recall
The nurse call cable (Part Number: QDF23-0571) on the FL23SE Bed is located right under the opening of the bed head box. If an accessory (i.e. IV pole) is inserted into this slot, the circuit directing the nurse call system can be damaged.
Root cause tag
design
FDA root cause
Device Design
Action
Stryker sent an Urgent Medical Device Recall Notification letter dated August 19, 2013, to all affected consignees. The notification described the affected product, reason for recall, potential hazards, and recall customer actions and reply instructions. A Stryker Representative will contact the consignees to arrange a time to repair the unit(s) and eliminate the risk of the potential interference . Urgent questions or concerns are directed to Blaine Burnett (269)389-6954. Stryker Medical business hours are Monday-Friday 8 a.m-5 p.m. (ET). For questions regarding this recall call 269-324-6609.
Quantity in commerce
61 units
Distribution
Worldwide Distribution - USA including MI, WI, VA and internationally to Canada.
Product codes and lots
Model Numbers: FL23SE with nurse call option: OL235017 & OL235018 List of Affected Devices: J60267 J60425 J60009 J60001 J60094 J60095 J60096 J60348 J60349 J60350 J60351 J60352 J60353 J60354 J60360 J60361 J60362 J60363 J60364 J60365 J60366 J60367 J60368 J60369 J60370 J60371 J60372 J60373 J60374 J60375 J60376 J60377 J60378 J60379 J60380 J60381 J60382 J60383 J60384 J60385 J60386 J60387 J60388 J60389 J60390 J60391 J60392 J60393 J60394 J60395 J60396 J60397 J60398 J60399 J60400 J60401 J60402 J60403 J60404 J60405 J60512

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2283-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2283-2013Class IITerminatedVoluntary: Firm initiated