—#65634

Product

Si emans Simiae 3000 Cassette Holder Electronic Imaging device (Image Identifier), with CT Part No: 19 57-161 or without CT Part No. 19 57 153; Siemens Medical Solutions USA, Concord, CA 94520

FDA product code: KPQ — System, Simulation, Radiation Therapy
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K946053
Affected lot / code info: Serial Numbers: 4164, 4062, 4114, 4037, 4155, 4125, 4180, 4096, 4064, 4107, 4145, 4144, 4143, 4081, 4172, 4152, 4090, 4161, 4181, 4093, 4066, 4054, 4091, 4068, 4128, 4179, 4019, 4023, 4117, 4094, 4015, 4083, 4174, 4074, 4082, 4011, 4078, 4034, 4063, 4025, 4171, 4086 4134, 4029, 4002, 4003, 4004, 4027, 4053, 4061, 4118, 4123, 4124, 4008, 4009, 4010, 4014, 4016, 4017, 4021, 4022, 4024, 4026, 4031, 4032, 4035, 4043, 4059, 4072, 4075, 4076, 4078, 4085, 4087, 4092, 4095, 4098, 4102, 4104, 4105, 4108, 4109, 4110, 4111, 4112, 4115, 4116, 4130, 4136, 4142, 4150, 4153, 4156, 4173, 70001004511, 40000296842, 4099, 4147, 4100, 4154, 4044, 4119, 4121, 4122, 4131, 4139, 4185, 4020, 4030, 4036, 4079, 4135, 4167, 4077, 4039, 4071, 4120, 41514127, 4176, 4097, 4049, 4046, 4070, 4084, 4138, 4160, 4165, 4028, 4042, 4101, 410, 4158, 4045, 4065, 4060, 4088, 4177, 4073, 4113, 4175, 4141, 4040, 4137, and 4052

Why it was recalled

Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient.

Root cause (FDA determination)

Labeling design

Action the firm took

Customers were sent a Customer Safety Advisory Notice on February 27, 2007, notifying them that the mounting screws on the cassette holders on the SIMVIEW 3000 and NT Simulators, as well as some MEVASIM Simulators, could loosen and can cause damage to the system, or personal injury. The firm requested that they check of tightness on the mounting hardware. A STOP Modification notice was issued on 06/01/2007, to all affected regional service organizations that are responsible for implementing updates due to new information. Updated letters and User instructions will be released in August 2007.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern: Worldwide Distribution - USA including states of IN, VA, MA, VT, NJ, NY, PA, DC, NC, SC, GA, AL, TN, MI, KY, OH, IN MI, MN, ND, MT, IL, MO, KS, NE, AR, OK, TX, AZ, CA, SD, LA, Puerto Rico, and countries of Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Colombia, Costa Rica, Croatia, Denmark, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hungary, India, Iran, Ireland, Italy, Kuwait, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, China, Israel/Palestine, Philippines, Poland, Portugal, Qatar, Republic of Korea, Russia, Singapore, South Africa, Spain, Thailand, Turkey, Ukraine, UK, and Vietnam.

Timeline

Recall initiated: 2007-02-27
Posted by FDA: 2008-01-31
Terminated: 2011-02-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #65634. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.