Events

Rappel de Device Recall Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Spacelabs Healthcare Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    73634
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1502-2016
  • Date de mise en oeuvre de l'événement
    2016-03-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144640
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Cause
    Reports of an abnormally high frequency of squelch events on xhibit telemetry receivers (xtr), which is indicative of the loss of the telemetry data signal. in some cases, the xhibit central monitor was also reported to display an xhibit offline error message for all patients being monitored.
  • Action
    On March 28, 2016, a customer letter will be sent via priority service, return receipt requested, to all U.S. customers. On April 4, 2016, a customer letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record. Spacelabs recommends that you brief your staff regarding the failure modes listed above. If you continue to use affected Telemetry Receiver(s), please note: **When there is a loss of signal, a signal loss alarm is generated and a triangular-shaped squelch waveform is displayed for any channel exhibiting signal loss. If unacknowledged, this alarm will escalate to medium priority after five minutes. After an additional five minutes, this alarm will escalate to high priority. This failure is usually transient. **When the XTR goes offline, all telemetry waveform(s) associated with the XTR will disappear from the Central Station and an offline message will appear in each telemetry waveform zone. This failure is not recoverable. Please circulate this notification to all persons affected by the information it contains and add a copy to the appropriate monitor user manual until such time as corrections have been implemented by Spacelabs. Spacelabs will contact you to schedule a convenient time for Spacelabs to update your Xhibit Telemetry Receivers at no cost. If you have any questions about this corrective action, please contact Spacelabs at 1-800-522-7025 and select 2 for Technical Support.

Device

Device Recall Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280
  • Modèle / numéro de série
    Affected PCBAs have no serial numbers. Below is the Part Numbers:  040-1736-00 KIT,UPGRADE,PCBA,QUAD RCVR,T BAND, 96280;  050-0758-00 REPLACEMENT KIT, PCBA,QUAD RCVR, Q BAND, 96280;  050-0759-00 REPLACEMENT KIT, PCBA,QUAD RCVR, T BAND, 96280; 050-0760-00 REPLACEMENT KIT, PCBA,QUAD RCVR, V BAND, 96280;  050-0758-00-X REPLACEMENT KIT, PCBA,QUAD RCVR, Q BAND, 96280 EXCHANGE;   050-0759-00-X REPLACEMENT KIT, PCBA,QUAD RCVR, T BAND, 96280 EXCHANGE;   050-0760-00-X REPLACEMENT KIT, PCBA,QUAD RCVR, V BAND, 96280 EXCHANGE;  050-0519-00 CM KIT,ET,600 MHZ-1400MHZ,NA, 96280; 050-0532-00 CM KIT,ET,400MHZ-600MHZ,INTERNATIONAL, 96280.  **************************SERIAL NUMBERS OF XTRs IN THE US************  6280-000051, 6280-000053, 6280-000056, 6280-000057, 6280-000058, 6280-000059, 6280-000066, 6280-000067, 6280-000068, 6280-000077, 6280-000078, 6280-000079, 6280-000080, 6280-000083, 6280-000084, 6280-000085, 6280-000086, 6280-000087, 6280-000088, 6280-000090, 6280-000092, 6280-000093, 6280-000095, 6280-000096, 6280-000097, 6280-000098, 6280-000099, 6280-000100, 6280-000101, 6280-000102, 6280-000103, 6280-000104, 6280-000105, 6280-000106, 6280-000107, 6280-000108, 6280-000109, 6280-000110, 6280-000111, 6280-000112, 6280-000113, 6280-000114, 6280-000115, 6280-000116, 6280-000117, 6280-000118, 6280-000119, 6280-000120, 6280-000121, 6280-000122, 6280-000123, 6280-000124, 6280-000125, 6280-000126, 6280-000127, 6280-000128, 6280-000129, 6280-000131, 6280-000132, 6280-000133, 6280-000135, 6280-000136, 6280-000137, 6280-000138, 6280-000140, 6280-000141, 6280-000142, 6280-000143, 6280-000145, 6280-000146, 6280-000147, 6280-000148, 6280-000149, 6280-000151, 6280-000152, 6280-000153, 6280-000154, 6280-000155, 6280-000156, 6280-000157, 6280-000158, 6280-000159, 6280-000160, 6280-000161, 6280-000167, 6280-000168, 6280-000169, 6280-000170, 6280-000171, 6280-000172, 6280-000173, 6280-000174, 6280-000175, 6280-000176, 6280-000177, 6280-000200, 6280-000227, 6280-000228, 6280-000229, 6280-000233, 6280-000234, 6280-000235, 6280-000236, 6280-000238, 6280-000239, 6280-000240, 6280-000241, 6280-000242, 6280-000243, 6280-000245, 6280-000248, 6280-000250, 6280-000251, 6280-000252, 6280-000253, 6280-000254, 6280-000255, 6280-000256, 6280-000257, 6280-000259, 6280-000260, 6280-000261, 6280-000263, 6280-000264, 6280-000265, 6280-000266, 6280-000267, 6280-000268, 6280-000269, 6280-000271, 6280-000272, 6280-000273, 6280-000274, 6280-000275, 6280-000278, 6280-000279, 6280-000280, 6280-000281, 6280-000283, 6280-000284, 6280-000285, 6280-000286, 6280-000287, 6280-000288, 6280-000289, 6280-000298, 6280-000299, 6280-000301, 6280-000302, 6280-000303, 6280-000304, 6280-000306, 6280-000307, 6280-000308, 6280-000309, 6280-000310, 6280-000311, 6280-000312, 6280-000313, 6280-000314, 6280-000315, 6280-000316, 6280-000319, and 6281-000144.     *********SERIAL NUMBERS OF XTRs OUTSIDE THE US************  6280-000048, 6280-000050, 6280-000052, 6280-000060, 6280-000061,  6280-000062, 6280-000063, 6280-000064, 6280-000065, 6280-000076,  6280-000094, 6280-000178, 6280-000179, 6280-000181, 6280-000182,  6280-000183, 6280-000184, 6280-000185, 6280-000186, 6280-000188, 6280-000189, 6280-000190, 6280-000191, 6280-000193, 6280-000194,  6280-000195, 6280-000196, 6280-000197, 6280-000198, 6280-000199,  6280-000202, 6280-000225, 6280-000226, 6280-000231, 6280-000232,  6280-000237, 6280-000246, 6280-000247, 6280-000249, 6280-000262,  6280-000270, 6280-000276, 6280-000282, 6280-000290, 6280-000291,  6280-000292, 6280-000293, 6280-000294, 6280-000295, 6280-000297,  6280-000300, 6280-000305, and 6280-000317.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    distributed in AL, AZ, CA, CO, CT, FL, ID, IN, KY, MI, MN, MO, MS, MT, SC, TX, WY and in the following countries: AUSTRALIA, CANADA, CHINA, FRANCE, NETHERLANDS, PHILIPPINES, ROMANIA, and UNITED KINGDOM.
  • Description du dispositif
    The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.
  • Manufacturer
    Spacelabs Healthcare Inc

Manufacturer

Spacelabs Healthcare Inc
  • Adresse du fabricant
    Spacelabs Healthcare Inc, 35301 SE Center St, Snoqualmie WA 98065-9216
  • Société-mère du fabricant (2017)
    OSI Systems Inc
  • Source
    USFDA