Respironics California Inc: The PL V Continuum ventilator is a microprocessor controlled, compressorbased, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. PL V Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The user interface on PL V Continuum has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient settings and for the display of alarm conditions. PL V Continuum is capable of providing the following types of ventilatory support: . Positive Pressure Ventilation, delivered either invasively (via endotracheal or tracheostomy tube) or non-invasively (via mask or mouthpiece). . Assist/Control, Spontaneous Intermittent Mandatory Ventilation (SIMV) or Continuous Positive Airway Pressure (CP AP) modes of ventilation. . Volume-Controlled (VC). Available in AlC and SIMV. . Pressure-Controlled (PC). Available in AlC and SIMV. . Pressure Support (PS). Available in SIMV and SPONT.

Recall number

Z-0354-06

Recalling firm

Respironics California Inc

Product

The PL V Continuum ventilator is a microprocessor controlled, compressorbased, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. PL V Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The user interface on PL V Continuum has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient settings and for the display of alarm conditions. PL V Continuum is capable of providing the following types of ventilatory support: . Positive Pressure Ventilation, delivered either invasively (via endotracheal or tracheostomy tube) or non-invasively (via mask or mouthpiece). . Assist/Control, Spontaneous Intermittent Mandatory Ventilation (SIMV) or Continuous Positive Airway Pressure (CP AP) modes of ventilation. . Volume-Controlled (VC). Available in AlC and SIMV. . Pressure-Controlled (PC). Available in AlC and SIMV. . Pressure Support (PS). Available in SIMV and SPONT.

Status

Terminated

Initiated

2005-11-18

Posted

2006-01-06

Terminated

2008-04-22

Reason

During product testing of the PLV Continuum Ventilator's Safety Valve/Pressure Relief Valve (SV/PRV) at our manufacturing facility, Respironics found that when the PLY Continuum Ventilator is operated in the 'Face Up' orientation, the SV /PRV may stick in the open position, which may result in loss of delivered gas volume to the patient.

Root cause

Other

Action

On November 18, 2005 all affected customers received a personal phone call from Respironics explaining the recall situation in detail. On November 21, 2005, an advisory notice was sent to customers via fax, email, or mail, instructing customers to only use your PLV Continuum Ventilator in the 'Face Foward' orientation. The firm will contact customers with further information shortly to assure that this situation is positively resolved. Customers were instructed to Only use the PL V Continuum Ventilator in the 'Face Forward' orientation. In the event that a customer requires the application of the PLV Continuum Ventilator in the Face Up Orientation, Respironics will provide the customer, at no charge, with a rental PLV-l00, PLV-IO2b or PLV-I02 Ventilator for the customer to use until their PLV Continuum Ventilator is upgraded. If additional information is needed the customer was instructed to contact Respironics'' Customer Service at 800 345-6443.

Quantity

268

Distribution

Nationwide, Taiwan, Saudi Arabia, Netherlands, Hong Kong, Canada, Brazil, Australia, and Argentina.

Lot, serial or model codes

Domestic Distribution Serial Numbers: VS4700581, VS4700661, VS4700631, VS4702578, VS4702507, VS4702551, VS4702583, VS4702589, VS4702590, VS470259], VS4702574, VS4702580, VS4702566, VS4700824, VS4702593, VS4700835, VS4700536, 1VS4700539, VS4700540, VS4700543, VS4700544, S4700546, VS4700548, VS4700549, VS4700550, VS4700552,VS4700554, VS4700555, VS4700558, VS4700565, VS4700566,VS4700567, VS4700569, VS4700573, VS4700574, VS4700577,VS4700578, VS4700580, VS4700581, VS4700585, VS4700588VS4700590, VS4700593, VS4700594, VS4700595, VS4700596, VS4700605, VS4700607, VS4700608, VS4700613, VS4700614, VS4700615, VS4700617, VS4700620, VS4700622, VS4700624, VS4700625, VS4700632, VS4700635, VS4700637, VS4700642, VS4700643, VS4700646, VS4700647, VS4700649, VS4700650, VS4700653, VS4700660, VS4700661, VS4700663, VS4700668, VS4700670, VS4700673, VS4700681, VS4700687, VS4700693, VS4700694, VS4700698, VS4700699, VS4700708, VS470071O, VS4700711, VS4700718, VS4700719, VS4700721, VS4700724, VS4700725, VS4700729, VS4700730, VS4700736, VS4700738, VS4700739, VS4700740, VS4700743, VS4700744, VS4700750, VS4700751, VS4700754, VS4700760, VS4700761, VS4700762, VS4700767, VS4700770, VS4700772, VS4700773, VS4700774, VS4700775, VS4700776, VS4700777, VS4700780, VS4700781, VS4700782, VS4700783, VS4700785, VS4700786, VS4700789, VS4700790, VS4700791, VS4700796, VS4700797, VS4700798, VS4700802, VS4700804, VS4700808, VS4700809, VS4700811, VS4700813, VS4700814, VS4700816, VS4700817, VS4700818, VS4700819, VS4700821, VS4700822, VS4700823, VS4700827, VS4700828, VS4700829, VS4700832, VS4700833, VS4700834, VS4700836, VS4700837, VS4700838, VS4700840, VS4700841, VS4700842, VS4700843, VS4700844, VS4700846, VS4700847, VS4700849, VS4700850, VS4700852, VS4700853, VS4700854, VS4700855, VS4700856, VS4702501, VS4702502, VS4702505, VS4702512, VS4702516, VS4702519, VS4702523, VS4702524, VS4702525, VS4702528, VS4702531, VS4702532, VS4702535, VS4702543, VS4702544, VS4702545, VS4702548, VS4702549, VS4702552, VS4702553, VS4702555, VS4702556, VS4702557, VS4702567, VS4702568, VS4702570, VS4702571, VS4702572, VS4702573, VS4702575, VS4702586, VS4702594, VS4702599, VS4702600, VS4702604, VS4702612, VS4702613, VS4702623, VS4702636, VS4702647, VS4702650, VS4702670, VS4702677, VS4702688, VS4702689, VS4702709, VS4702734, VS4702747, VS4702748, VS4702750, VS4702776, VS4702784, VS4702800, VS4702805, VS4702809, VS4702811, VS4702813, VS4702825, VS4702835, VS4702848, VS4702854, VS4702856, VS4702857, VS4702859, VS4702883, VS4702885, VS4702981, VS4703079, VS4703103  International Distribution Serial Numbers: VS4702605, VS4702608, VS4702609, VS4702631, VS4702632, VS4702634, VS4702642, VS4702643, VS4702659, VS4702719, VS4702754, VS4702759, VS4700792, VS4702722, VS4700563, VS4700696, VS4700820, VS4700601, VS4702645, VS4700839, VS4700644, VS4700589, VS4700703, VS4700723, VS4700746, VS4700553, VS4700628, VS4702962, VS4702983, VS4702995, VS4703006, VS4703023, VS4703041, VS4703056, VS4703064, VS4700717, VS4700645, VS4702915, VS4702500, VS4702828, VS4702858

510(k) numbers

["K022750"]

PMA numbers

not on file

Product code

CBK

Firm FEI

2518422

Firm city

Carlsbad

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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