Device, Spot-film
Radiology · 21 CFR 892.1670
Recent MDR events
30 adverse event reports on file
- Unnamed deviceOct 30, 2025No answer providedCOR25000420-000
- Unnamed deviceJul 30, 2024No answer providedCOR24000151-000
- Unnamed deviceMay 1, 2024No answer providedCOR24000079-000
- OPTIMA 220ROct 29, 2012Ge Medical Systems, Llc2839336
- DIAGNOST 76Jul 7, 2011MalfunctionPhilips Medical Systems Dmc Gmbh3003768251-2011-00041
- DIAGNOST 76PLUSDec 15, 2010MalfunctionPhilips Medical Systems3003768251-2010-00068
- DIAGNOST 76Oct 25, 2010MalfunctionPhilips Medical Systems3003768251-2010-00041
- DIAGNOST 76Sep 9, 2010MalfunctionPhilips Medizin Systeme3003768251-2010-00024
- DIAGNOST 56/66/76Sep 9, 2010MalfunctionPhilips Medizin Systeme3003768251-2010-00023
- DIAGNOST 56/66/76Jan 14, 2008MalfunctionPhilips Medical Systems1217116-2008-00006
Event type breakdown
Recalls
3 recall events for this product code
- Philips Medical Systems North America Co. PhillipsTerminatedMar 8, 2011
Philips BV Endura, Rel. 2, 718074.
The fixing strap of the belt holding the CBX Laser to the Image Intensifier may be detached during a procedure when used with the BV Libra and the BV Pulsera/Endura Systems.
Z-1604-2011 · View FDA record ↗ - Philips Medical Systems North America Co. PhillipsTerminatedMar 8, 2011
Philips BV Pulsera, Rel. 2.3, 718095.
The fixing strap of the belt holding the CBX Laser to the Image Intensifier may be detached during a procedure when used with the BV Libra and the BV Pulsera/Endura Systems.
Z-1605-2011 · View FDA record ↗ - Philips Medical Systems North America Co. PhillipsTerminatedSep 13, 2010
Diagnost 56/66/76/76 Plus, DSI is a Spot-Film and has a Digital Imaging Spot.
Potential for the tower (holding the serial changer and/or image intensifier) to slide unexpectedly and potentially injure a patient or user in its path.
Z-2404-2010 · View FDA record ↗
Registered firms
8 firms currently registered for this product code
Philips India Limited - Diagnostic X-ray Business Unit
Pimpri Maharashtra, IN
Philips Electronics Ltd
Mississauga Ontario, CA
Philips Medical Systems Dmc Gmbh
HAMBURG, DE
Villa Sistemi Medicali S.p.a.
BUCCINASCO Milano, IT
Philips India Limited - Diagnostic X-ray Business Unit
Bengaluru Karnataka, IN
Can Technomed Trading Ltd.
Richmond British Columbia, CA
510(k) clearances
13 clearances for this product code
- Ge Medical Systems, LLCJul 19, 2011
K111304 · OPTIMA XR120
- Fischer Imaging Corp.Mar 4, 1997
K964806 · MD-1835
- GE Medical SystemsFeb 8, 1995
K950317 · ADVANTX 1824 SPOTFILM DEVICE
- Eastman Kodak CompanyAug 17, 1994
K940386 · KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP
- Applied X-Ray Technologies, Inc.Jun 6, 1994
K942367 · AXT 1400 SPOTFILM DEVICE
- Philips Medical Systems, Inc.Nov 24, 1992
K924593 · DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4
- Rms Div.Aug 1, 1990
K902403 · ELITE R/F SPOT FILM DRIVE
- Rms Div.May 31, 1990
K902146 · SFD-035 SPOT FILM DEVICE