Events

Rappel de HillRom 100 Bed

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 Hill-Rom, 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
    55156
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2268-2010
  • Date de mise en oeuvre de l'événement
    2009-04-13
  • Date de publication de l'événement
    2010-08-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90161
  • 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
    hospital bed - Product Code FNL
  • Cause
    Pinch hazard. potential for shearing action between the side rail arm and the bracket used to secure the side rail to the bed.
  • Action
    Hill-Rom sent a customer notification letter dated 4/9/2009. A second notice was sent to all customers on 7/9/2009. The letter included instructions and a Customer Response Form, along with the required parts. Customers were instructed to do the correction on their affected beds and return the completed customer response form within 45 days.

Device

HillRom 100 Bed
  • Modèle / numéro de série
    K029AP6787, K029AP6788, K029AP6790, J317AP5267, J206AP2503, J206AP2506, J206AP2511, J206AP2513, J213AP2581, J220AP2773, J220AP2775, J220AP2777, J220AP2778, J224AP2904, J224AP2906, J224AP2907, J224AP2908, J220AP2770, J224AP2909, J224AP2916, J227AP3052, J227AP3053, K027AP6733, K027AP6735, K027AP6736, K027AP6738, J220AP2772, J220AP2774, J224AP2905, J274AP4108, J274AP4113, J274AP4114, J274AP4134, J274AP4135, J274AP4136, J274AP4102, J350AP5889, J350AP5890, J350AP5891, J350AP5892, J350AP5893, J350AP5894, J350AP5895, J350AP5896, J350AP5897, J350AP5899, J350AP5900, J350AP5901, J350AP5902, J350AP5903, J350AP5904, J350AP5905, J350AP5906, J350AP5907, J350AP5908, J350AP5909, J350AP5998, J352AP5988, J352AP5989, J352AP5990, J352AP5991, J352AP5992, J352AP5993, J352AP5994, J352AP5995, J352AP5996, J352AP5997, J352AP5998, J352AP5999, J352AP6000, J352AP6001, J352AP6002, J352AP6003, J352AP6004, J352AP6005, J352AP6006, J352AP6007, J352AP6008, J352AP6009, J352AP6010, J352AP6011, J352AP6012, K020AP6555, K020AP6556, K020AP6557, K020AP6558, K020AP6559, K020AP6560, J354AP6044, J354AP6045, J354AP6046, J354AP6047, J354AP6048, J354AP6049, J354AP6050, J354AP6051, J354AP6052, J354AP6053, J354AP6054, J354AP6056, J354AP6057, J354AP6058, J354AP6059, J354AP6042, J354AP6043, J274AP4103, J274AP4105, J274AP4106, J274AP4107, J274AP4109, J274AP4110, J274AP4111, J274AP4115, J274AP4117, J274AP4118, J274AP4120, J274AP4125, J274AP4127, J274AP4129, J274AP4132, J274AP4137, J274AP4138, J282AP4359, J282AP4365, J282AP4366, J324AP5383, J324AP5384, J324AP5385, J324AP5386, K027AP6720, K027AP6723, K027AP6726, K027AP6727, K027AP6728, K027AP6729, K027AP6730, K027AP6731, K027AP6732, K027AP6734, K027AP6737, K027AP6739, K027AP6740, K027AP6741, K027AP6742, K028AP6773, K028AP6774, K038AP6999, K038AP7000, K038AP7001, K038AP7002, J274AP4099, J274AP4100, J274AP4112, J274AP4116, J274AP4119, J274AP4122, J274AP4126, J274AP4131, J206AP2509, J213AP2580, J220AP2764, J220AP2767, J227AP3035, J227AP3036, J227AP3037, J227AP3039, J227AP3040, J227AP3041, J227AP3042, J227AP3043, J227AP3044, J227AP3045, J227AP3046, J227AP3047, J227AP3048, J227AP3049, J227AP3051, J206AP2508, J206AP2512, J213AP2578, J213AP2579, J206AP2505, J220AP2761, J220AP2762, J220AP2763, J220AP2765, J220AP2766, J220AP2768, J220AP2769, J227AP3038, J274AP4097, J274AP4098, J274AP4104, J274AP4128, J274AP4130, J274AP4133, K006AP6220, K006AP6221, J309AP4986, J309AP4987, J309AP4988, J309AP4989, J309AP4990, J309AP4991, J143AP0940, J143AP0941, J143AP0937, J143AP0944, J143AP0943, J220AP2788, J220AP2789, J274AP4121, J206AP2504, J206AP2507, J206AP2510, J206AP2514, J240AP3514, J317AP5268, J317AP5269, J143AP0945, J143AP0946, J220AP2771, J220AP2776, J220AP2779, J220AP2780, J220AP2781, J220AP2790, J220AP2791, J220AP2792, J227AP3054, J227AP3055, J227AP3056, J239AP3425, J239AP3426, J239AP3428, J239AP3429, J239AP3430, J239AP3431, J239AP3432, J143AP0939, J354AP6055 and J303AP4873.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA, Afghanistan, Algeria, American Samoa, Argentina, Australia, Bermuda, Brazil, Canada, Chili, China, Colombia, Costa Rica, Cuba, Ecuador, Egypt, Hong Kong, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Kyrgyzstan, Lebanon, Libya, Malaysia, Mexico, Oman, Panama, Paraguay, Philippines, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Korea, Syria, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Yemen.
  • Description du dispositif
    Hill-Rom 1000 bed model P1160.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Adresse du fabricant
    Hill-Rom, Inc., 125 E Pearl St, 1069 State Route 46 East, Batesville IN 47006
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA