Reported Dec 15, 2021 · Ongoing
OsteoMed OsteoPower Power Console
Osteomed, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Osteomed, LLC · 3885 Arapaho Rd · Addison, TX · 75001-4314
Is this the product you have?
OsteoMed OsteoPower Power Console
11 of 11 products
| Model / number | Product as published |
|---|---|
450-0021-00 | OsteoMed D-Power Control Console 2 |
450-0021-01 | Power Control Console 2 |
ECOS-450-0021-00 | OsteoMed OsteoPower Power Console 2i |
450-0005-00 | OsteoMed D-Power Control Console 2i |
450-0005-01 | Power Control Console 2i |
ECOS-450-0005-00 | OsteoMed Footswitches: -OsteoMed BMF Footswitch |
450-0390 | D-Bi-Directional Master Footswitch |
450-0380 | D-Uni-Directional Footswitch II |
450-0350 | D-Bi-Directional Footswitch II |
450-0360 | D-Uni-Directional Master Footswitch |
450-0370 | — |
- Lot codes and dates
- Product#/Brand
- Name/UDI Code450-0005-00 / OsteoMed OsteoPower Power Console 2i / 0084569401211 450-0021-00 / OsteoMed OsteoPower Power Console 2 / 0084569401215 450-0390 / OsteoMed BMF Footswitch / 0084569401215 450-0005-01 / OsteoMed D-Power Control Console 2i / 0084569401211 450-0021-01 / OsteoMed D-Power Control Console 2 / 0084569401211 ECOS-450-0021-00 / Power Control Console 2 / 0084569401211 ECOS-450-0005-00 / Power Control Console 2i / 0084569401211
- Serial Numbers0332004 450-0005-01 0422006 450-0005-00 0423001 450-0005-01 0434003 S 0434004 S 0434010 S========================================================= -450-0380 / D-Bi-Directional Master Footswitch / 0084569401215 -450-0350 / D-Uni-Directional Footswitch II / 0084569401215 -450-0360 / D-Bi-Directional Footswitch II / 0084569401215 -450-0370 / D-Uni-Directional Master Footswitch / 0084569401215
528 of 528 codes
04430040423005450-0005-010449004s0509004S0509005S050602704450030445005991200305150090525014053200105210420521045053500605350070537031053703205370330537034054000505470220551022055102505520080552009061100406040700616001061600206150050615009061501006150390616003061600506150410620004062000506220220622023063302406410040643068064500206450030641009064802306480250649002064900307010040702021070100506400040701006070100907040360651097
- Serial Numbers0427013 450-0390 0427014 450-0390 0433007 S 0433012 S 0433016 S 0433025 S0433004*
0438004S0438021S0446004S0446016S0446013S0446014S0446022S051901005190110204001450-03500204002
s173 of 173 codes
051902505260190526020052602105260330601019060102006050260605027060503306050320614008061401906140240614036061403706140420624003062400606240070638041062402006380500638051063806006430490643054064306406430650650013065001406500150650017065002006500210650025065002806500290702002070200407080060708007071802507180260736005070201507390130103013973700107390160739017073901807430200743018074302307430250751058075105707510600751064
395 of 395 codes
134601313460141346016134601713460180222025101801113460191404005134601214040041405011140800514250031425004142500914360061436007143600814360091436011143601214360131441007144101114410091441012144701414470150831008150102815090161511021151102315110241509014150901515110221511025151600615160071516008151601215160131523003152300315230041523005152300515230061523006152300815230111523010152802015280210718022153605215360531536057
- Amount recalled
- 533 consoles and 586 footswitches
Where it was sold
Why it was recalled
Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
This product could cause temporary or reversible health problems — stop using it.
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