Z-2178-2014 Class III Terminated
FDA device recall Z-2178-2014 was initiated by AGFA Healthcare Corp. on Jul 16, 2014 and is designated Class III. Reason for recall: Some sheets of the medical screen film are fogged. The recall status is terminated (terminated Dec 9, 2014). Affected quantity: 2617.
Recall details
- Product Type
- Devices
- Report Date
- Aug 20, 2014
- Initiation Date
- Jul 16, 2014
- Termination Date
- Dec 9, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2617
Product description
Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.
Reason for recall
Some sheets of the medical screen film are fogged.
Distribution pattern
Worldwide Distribution and US Nationwide in the states of AL, AZ, CA, FL, IL, LA, MI, MN, MS, NE, NH, NJ, NC and country of Canada
Code information
Lot Batch No. 79350052, 79380052, 79390074, 79400066, 79410063
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2178-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026