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U.S. Department of Health and Human Services

Class 2 Device Recall LEO Scooter

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  Class 2 Device Recall LEO Scooter see related information
Date Initiated by Firm December 07, 2011
Date Posted January 17, 2012
Recall Status1 Terminated 3 on July 02, 2013
Recall Number Z-0774-2012
Recall Event ID 60670
510(K)Number K090735  
Product Classification Vehicle, motorized 3-wheeled - Product Code INI
Product Leo 3-Wheel Scooter and Leo Scooter, Distributed By:
Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035

Intended to provide transportation for a disabled or elderly person.
Code Information Model # LEO-4B; Serial # 10MCT000110, 10MCT000111, 10MCT000112, 10MCT000113, 10MCT000114, 10MCT000115, 10MCT000116, 10MCT000117, 10MCT000118, 10MCT000119, 10MCT000120, 10MCT000121, 10MCT000122, 10MCT000123, 10MCT000124, 10MCT000125, 10MCT000126, 10MCT000127, 10MCT000128, 10MCT000129, 10MCT000130, 10MCT000131, 10MCT000132, 10MCT000133, 10MCT000134, 10MCT000135, 10MCT000136, 10MCT000137, 10MCT000138, 10MCT000139, 10MCT000140, 10MCT000141, 10MCT000142, 10MCT000143, 10MCT000144, 10MCT000145, 10MCT000146, 10MCT000147, 10MCT000148, 10MCT000149, 10MCT000150, 10MCT000151, 10MCT000152, 10MCT000153, 10MCT000154, 10MCT000155 & 10MCT000156. Model # LEO-4S; Serial # 10MCT000001, 10MCT000002, 10MCT000003, 10MCT000004, 10MCT000005, 10MCT000006, 10MCT000007, 10MCT000008, 10MCT000009, 10MCT000010, 10MCT000011, 10MCT000012, 10MCT000013, 10MCT000014, 10MCT000015, 10MCT000016, 10MCT000017, 10MCT000018, 10MCT000019, 10MCT000020, 10MCT000021, 10MCT000022, 10MCT000023, 10MCT000024, 10MCT000025, 10MCT000026, 10MCT000027, 10MCT000028, 10MCT000029, 10MCT000030, 10MCT000031, 10MCT000032, 10MCT000033, 10MCT000034, 10MCT000035, 10MCT000036, 10MCT000037, 10MCT000038, 10MCT000039, 10MCT000040, 10MCT000041, 10MCT000042, 10MCT000043, 10MCT000044, 10MCT000045, 10MCT000046, 10MCT000047, 10MCT000048, 10MCT000049, 10MCT000050, 10MCT000051, 10MCT000052, 10MCT000053, 10MCT000054, 10MCT000055, 10MCT000056, 10MCT000057, 10MCT000058, 10MCT000059, 10MCT000060, 10MCT000061, 10MCT000062, 10MCT000063, 10MCT000064, 10MCT000065, 10MCT000066, 10MCT000067, 10MCT000068, 10MCT000069, 10MCT000070, 10MCT000071, 10MCT000072, 10MCT000073, 10MCT000074, 10MCT000075, 10MCT000076, 10MCT000077, 10MCT000078, 10MCT000079, 10MCT000080, 10MCT000081, 10MCT000082, 10MCT000083, 10MCT000084, 10MCT000085, 10MCT000086, 10MCT000087, 10MCT000088, 10MCT000089, 10MCT000090, 10MCT000091, 10MCT000092, 10MCT000093, 10MCT000094, 10MCT000095, 10MCT000096, 10MCT000097, 10MCT000098, 10MCT000099, 10MCT000100, 10MCT000101, 10MCT000102, 10MCT000103, 10MCT000104, 10MCT000105, 10MCT000106, 10MCT000107, 10MCT000108, 10MCT000109, 10MDG0001, 10MDG0002, 10MDG0003, 10MDG0004, 10MDG0005, 10MDG0006, 10MDG0007, 10MDG0008, 10MDG0009, 10MDG0010, 10MDG0011, 10MDG0012, 10MDG0013, 10MDG0014, 10MDG0015, 10MDG0016, 10MDG0017, 10MDG0018, 10MDG0019, 10MDG0020, 10MDG0021, 10MDG0022, 10MDG0023, 10MDG0024, 10MDG0025, 10MDG0026, 10MDG0027, 10MDG0028, 10MDG0029, 10MDG0030, 10MDG0047, 10MDG0048, 10MDG0049, 10MDG0050, 10MDG0051, 10MDG0052, 10MDG0053, 10MDG0054, 10MDG0055, 10MDG0056, 10MDG0057, 10MDG0058, 10MDG0059, 10MDG0060, 10MDG0061, 10MDG0062, 10MDG0063, 10MDG0064, 10MDG0065, 10MDG0066, 10MDG0067, 10MDG0068, 10MDG0069, 10MDG0070, 10MDG0071, 10MDG0072, 10MDG0073, 10MDG0074, 10MDG0075, 10MDG0076, 10MDG0077, 10MDG0078, 10MDG0079, 10MDG0080, 10MDG0081, 10MDG0082, 10MDG0083, 10MDG0084, 10MDG0085, 10MDG0086, 10MDG0087, 10MDG0088, 10MDG0089, 10MDG0090, 10MDG0091, 10MDG0092, 10MDG0093, 10MDG0094, 10MDG0095, 10MDG0096, 10MDG0097, 10MDG0098, 10MDG0099, 10MDG0100, 10MDG0101, 10MDG0102, 10MDG0103, 10MDG0104, 10MDG0105, 10MDG0106, 10MDG0107, 10MDG0108, 10MDG0109, 10MDG0110, 10MDG0111, 10MDG0112, 10MDG0113, 10MDG0114, 10MDG0115, 10MDG0116, 10MDG0117, 10MDG0118, 10MDG0119, 10MDG0120, 10MDG0121, 10MDG0122, 10MDG0123, 10MDG0124, 10MDG0125, 10MDG0126, 10MDG0127, 10MDG0128, 10MDG0129, 10MDG0130, 10MDG0131, 10MDG0132, 10MDG0133, 10MDG0134, 10MDG0135, 10MDG0151, 10MDG0152, 10MDG0153, 10MDG0154, 10MDG0155, 10MDG0156, 10MDG0157, 10MDG0158, 10MDG0159, 10MDG0160, 10MDG0161, 10MDG0162, 10MDG0163, 10MDG0164, 10MDG0165, 10MDG0166, 10MDG0167, 10MDG0168, 10MDG0169, 10MDG0170, 10MDG0171, 11ADG0001, 11ADG0002, 11ADG0003, 11ADG0004, 11ADG0005, 11ADG0006, 11ADG0007, 11ADG0008, 11ADG0009, 11ADG0010, 11ADG0011, 11ADG0012, 11ADG0013, 11ADG0014, 11ADG0015, 11ADG0016, 11ADG0017, 11ADG0018, 11ADG0019, 11ADG0020, 11ADG0021, 11ADG0022, 11ADG0023, 11ADG0024, 11ADG0025, 11ADG0026, 11ADG0027, 11ADG0028, 11ADG0029, 11ADG0030, 11ADG0031, 11ADG0032, 11ADG0033, 11ADG0034, 11ADG0035, 11ADG0036, 11ADG0037, 11ADG0038, 11ADG0039, 11ADG0040, 11ADG0041, 11ADG0042, 11ADG0073, 11ADG0074, 11ADG0075, 11ADG0076, 11ADG0077, 11ADG0078, 11ADG0079, 11ADG0080, 11ADG0081, 11ADG0082, 11ADG0083, 11ADG0084, 11ADG0085, 11ADG0086, 11ADG0087, 11ADG0088, 11ADG0089, 11ADG0090, 11ADG0091, 11ADG0092, 11ADG0093, 11ADG0094, 11ADG0095, 11ADG0096, 11ADG0097, 11ADG0098, 11ADG0099, 11ADG0100, 11ADG0101, 11ADG0102, 11ADG0103, 11ADG0104, 11ADG0105, 11ADG0106, 11ADG0107, 11ADG0108, 11ADG0109, 11ADG0110, 11ADG0111, 11ADG0112, 11ADG0113, 11ADG0114, 11ADG0115, 11ADG0116, 11ADG0117, 11ADG0118, 11ADG0119, 11ADG0120, 11ADG0121, 11ADG0122, 11ADG0123, 11ADG0124, 11ADG0125, 11ADG0126, 11ADG0127, 11ADG0128, 11ADG0129, 11ADG0130, 11ADG0131, 11ADG0132, 11ADG0133, 11ADG0134, 11ADG0135, 11ADG0136, 11ADG0137, 11ADG0138, 11ADG0139, 11ADG0140, 11ADG0141 & 11ADG0142.
Recalling Firm/
Manufacturer		 Invacare Corporation
1 Invacare Way
Elyria OH 44035-4190
For Additional Information Contact
440-329-6595
Manufacturer Reason
for Recall		 Invacare Corporation decided to recall the products because the scooter backrest fails unexpectedly due to seat flexing, and this has the potential to result in a consumer falling causing death or serious injury.
FDA Determined
Cause 2		 Device Design
Action On 12/7/2011 the firm sent Urgent: Recall Information Letters to their customers. The letter informed customers of the affected product and the related problem. The letter also states that Invacare has developed replacement seat kits intended to replace the original seats. The replacement kit will be provided free of charge and can be ordered by completing and returning the attached response card. After receiving replacement kits, customers are asked to contact their customers that have potentially affected devices and replace the seats immediately. Questions should be directed to Customer Service at 1-800-333-6900.
Quantity in Commerce 391 scooters
Distribution Worldwide Distribution -- USA, including the states of AK, CA, FL, GA, HI, IA, ID, IL, KS, LA, MD, MI, MN, MO, MT, NC, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA, & WI, and the countries of AUSTRIA, BELGIUM, CZECH REPUBLIC, ESTONIA, FRANCE, GERMANY, IRELAND, ITALY, JERSEY (CHANNEL ISLANDS), LITHUANIA, PORTUGAL, SWEDEN, SWITZERLAND, & UNITED KINGDOM.
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.
510(K) Database 510(K)s with Product Code = INI and Original Applicant = C.T.M. HOMECARE PRODUCT, INC.
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