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Class 2 Device Recall Invacare TDX SP2 |
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Date Initiated by Firm |
March 30, 2022 |
Create Date |
May 25, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1130-2022 |
Recall Event ID |
90084 |
510(K)Number |
K170507
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Product Classification |
Wheelchair, powered - Product Code ITI
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Product |
Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V |
Code Information |
UDI (DI):
Model Number Device Identifier
TDXSP2 00841447100911
TDXSP2-MCG 00841447100966
TDXSP2V 00841447101512
Serial Numbers:
22CE000031
22BE004288
22BE002669
22BE003672
22BE004782
22BE004151
22CE000984
22BE004286
22BE004171
22BE004540
22CE001086
22BE003661
22CE000184
22CE000878
22CE001449
22CE000032
22CE001421
22BE004933
22CE001002
22CE000180
22CE000725
22BE004544
22BE005009
22BE003671
22BE004284
22BE004159
22BE004285
22BE002652
22BE004282
22BE004798
22BE004281
22BE004170
22CE000182
22CE000183
22CE000876
22CE000873
22CE000981
22CE000870
22CE000871
22CE001248
22CE001004
22CE001084
22BE004776
22BE004165
22BE004931
22BE005010
22CE000875
22CE000728
22CE000727
22BE004910
22BE004904
22BE005007
22BE004160
22BE004169
22BE004175
22BE004166
22BE004905
22CE001420
22CE000496
22BE003645
22BE002651
22CE000999
22CE001078
22BE004545
22BE004763
22BE003662
22BE004929
22BE004937
22BE004176
22BE004903
22CE000181
22BE004167
22BE005006
22BE002666
22BE004177
22BE003962
22BE003957
22BE004173
22BE003664
22BE003659
22BE004767
22BE004940
22BE004777
22BE004538
22CE000186
22CE000867
22BE002935
22BE003959
22CE000493
22CE001077
22BE002934
22CE000726
22BE005004
22CE001251
22BE003961
22BE003673
22BE004902
22BE002936
22BE004801
22BE004287
22BE004995
22BE004539
22CE001075
22CE000490
22CE000879
22BE004168
22CE000847
22CE000033
22CE001005
22CE001006
22BE004765
22BE004768
22BE004769
22BE004770
22BE004911
22BE002932
22BE003960
22CE000874
22CE001253
22BE004930
22CE000178
22CE000179
22CE001080
22BE004174
22BE003963
22BE004935
22BE004775
22BE004172
22CE000177
22BE004543
22BE004764
22BE004766
22CE001076
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Recalling Firm/ Manufacturer |
Invacare Corporation 1200 Taylor St Elyria OH 44035-6248
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For Additional Information Contact |
Invacare Support Line 877-413-6008
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Manufacturer Reason for Recall |
The battery wiring harness on affected wheelchairs may become disconnected during shipment from the factory or during wheelchair use traversing large obstacles or after a jolt or impact to the wheelchair. The disconnection of the battery harness results in loss of power to the wheelchair.
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FDA Determined Cause 2 |
Device Design |
Action |
A preliminary notification was sent to providers on March 30, 2022, introducing the product issue and providing instructions regarding how to handle impacted units before field correction kits are available.
A notification letter dated April 13, 2022, was sent to impacted consignees via traceable mail. This mailing includes a Provider Letter which will introduces the field correction requirements and provides instructions for acknowledging awareness and understanding of the requested field correction activities.
Providers should inform affected customers to inform them that their wheelchair is subject to recall and requires repair. The letter provides user precautions that must be taken until the wheelchair is repaired.
If you have any questions concerning this recall, please call Invacare s field correction support line at (877) 413-6008 |
Quantity in Commerce |
133 devices |
Distribution |
Worldwide distribution - US Nationwide distribution in the states of AK, AR, CA, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA, and WI. The country of Canada. |
Total Product Life Cycle |
TPLC Device Report
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = ITI and Original Applicant = Invacare Corporation
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