Accutron Inc

Entity profile compiled from public source records

Public Record Profile Registrations: 1 510(k) filings: 0 Recalls: 4

Known Identifiers & Locations

FEI Numbers 2020813
Owner Operator Numbers 2020813
Locations Covered PHOENIX, AZ, US

Registered Establishments (1)

Registration # Establishment Name Location Establishment Type(s) Action
2020813 ACCUTRON, INC. PHOENIX, AZ, US Repack or Relabel Medical Device View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (4)

Recall # Product Description Initiation Date Status Action
Z-0017-2013 Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. Flowmeter, CM Assembly, Model#31970, Serial#13692. Product Usage: Conscious Sedation Unit Analgesia Gas Machine. Reason: Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner. 2012-04-29 Terminated View Details
Z-0018-2013 Ultra PC% Cabinet Mount Package G, Model #36600, Serial # 13593, 13594, 13595, 13596, 13597, 13598, 13599, 13600, 13602, 13605, 13610, 13611, 13612, 13615, 13616, 13617, 13621, 13622, 13624, 13625, 13627, 13628, 13633, 13634, 13635, 13636, 13637, 13638, 13639, 13640, 13642, 13643, 13644, 13647, 13650, 13669, 13675, 13673, 13678, 13679, 13680, 13683, 13685, 13687, 13691, 13693, 13694, 13695, 13696, 13697, 13701, 13702, 13705, 13706, 13709, 13710, 13711, 13724, 13725, 13728, 13729, 13735, 13739, 13743, 13746, 13750, 13751, 13753, 13754, 13755, 13756, 13760, 13762, 13766, 13774, 13775, 13777, 13781, 13782, 13783, 13785, 13786, 13788, 13792, 13794, 13796, 13799, 13800, 13803, 13804, 13809, 13810, 28298, 28299, 28304, 28305, 28306, 28307, Ultra PC% Cabinet Mount Pkg I, Model #36800, Serial # 13601, 13603, 13607, 13608, 13609, 13613, 13618, 13620, 13623, 13626, 13629, 13630, 13631, 13632, 13641, 13645, 13646, 13648, 13649, 13651, 13652, 13653, 13654, 13655, 13656, 13657, 13658, 13659, 13660, 13661, 13665, 13666, 13667, 13668, 13671, 13672, 13674, 13676, 13677, 13684, 13688, 13689, 13698, 13700, 13707, 13723, 13727, 13730, 13732, 13734, 13741, 13742, 13757, 13758, 13759, 13761, 13762, 13763, 13764, 13765, 13767, 13769, 13789, 13790, 13791, 13795, 13797, 13801, 13802, 13806, 13808, 28300, 28302, 28303, Ultra PC% Cabinet Mount Pkg G, Model#36600-NS, Serial# 13805, 13807, 13811, 13812. Ultra PC% Cabinet Mount Pkg H, Model#36800-NS, Serial# 13744, 13745,13752, 13773, 13774, 13778, 13779, 13780 Product Usage: Conscious Sedation Unit Analgesia Gas Machine. Reason: Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner. 2012-04-29 Terminated View Details
Z-0019-2013 CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine. Reason: Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner. 2012-04-29 Terminated View Details
Z-0020-2013 Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740, 13768, 13770, 13771, 13772, 13784, 13787. Product Usage: Portable Analgesia Gas Machine. Reason: Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner. 2012-04-29 Terminated View Details

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