FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: 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
- Recall number
- Z-0281-2008
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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
- Status
- Terminated
- Initiated
- 2007-02-27
- Posted
- 2008-01-31
- Terminated
- 2011-02-03
- Reason
- Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient.
- Root cause
- Labeling design
- Action
- 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.
- Quantity
- 287 units total, all recalls Z-0281-285-2008
- Distribution
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K946053"]
- PMA numbers
- not on file
- Product code
- KPQ
- Firm FEI
- 2937457
- Firm city
- Concord
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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