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U.S. Department of Health and Human Services

Class 2 Device Recall GSeries

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  Class 2 Device Recall GSeries see related information
Date Initiated by Firm December 05, 2014
Date Posted February 02, 2015
Recall Status1 Terminated 3 on June 18, 2015
Recall Number Z-1036-2015
Recall Event ID 69450
Product Classification Bed, ac-powered adjustable hospital - Product Code FNL
Product G- Series Beds; G29 full length bed rails assembly
Code Information Model G5510 Date codes:  40121 40122 40130 40131 40201 40204 40205 40206 40210 40211 40212 40213 40214 40217 40218 40219 40220 40221 40224 40225 40226 40227 40228 40303 40304 40305 40306 40307 40310 40311 40312 40313 40314 40319 40325 40326 40327 40331 40401 40402 40403 40404 40410 40411 40414 40415 40416 40421 40422 40423 40424 40425 40429 40429 40430 40501 40502 40506 40507 40508 40512 40513 40514 40515 40516 40519 40520 40521 40522 40523 40526 40527 40528 40529 40530 40603 40604 40605 40606 40610 40611 40612 40613 40616 40617 40618 40619 40620 40623 40624 40625 40626 40627 40630 40701 40702 40703 40707 40708 40709 40714 40715 40716 40717 40721 40722 40723 40724 40728 40729 40730 40731 40805 40806 40807 40811 40812 40813 40818 40819 40820 40825 40826 40901 40902 40904 
Recalling Firm/
Manufacturer		 Invacare Corporation
1200 Taylor St
Elyria OH 44035-6248
For Additional Information Contact Swasita Saigal
440-329-6875
Manufacturer Reason
for Recall		 Invacare identified that the rail mounting bracket on the G29 full length bed rail was out of specification for entrapment safety.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Invacare sent an Urgent Medical Device Recall letter dated December 5, 2014, to all affected customers. The letter identified the product and the problem. Customers with questions should call 440-329-7996. For questions regarding this recall call 440-329-6875.
Quantity in Commerce 2499 units
Distribution US Nationwide Distribution including OH, CO, MO, and NY.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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