FDA Medical Device Recalls (openFDA)
Philips Medical Systems North America Co. Phillips: Practix 33 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and are specifically used as mobile X-ray systems for bedside radiological examinations.
- Recall number
- Z-0762-2007
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Product
- Practix 33 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and are specifically used as mobile X-ray systems for bedside radiological examinations.
- Status
- Terminated
- Initiated
- 2007-03-23
- Posted
- 2007-09-25
- Terminated
- 2010-09-16
- Reason
- X-ray systems lack product report certification demonstrating compliance, and were illegally introduced into the United States commerce.
- Root cause
- Other
- Action
- The firm sent letters out via certified mail from 04/03/2007 through 04/09/2007 to consignees informing them of the issue. The letter indicates that the firm plans to replace consignee's systems with the Practix Convenio Mobile X-ray System at no charge by the end of May 2007.
- Quantity
- 9 units
- Distribution
- Nationwide: Distributed to Puerto Rico.
- Lot, serial or model codes
- Serial Numbers: P5-546; P5-370; P5-547; P5-529; P5-371; P5-426; PS-686; P5-727, and P5-548
- 510(k) numbers
- ["K042368"]
- PMA numbers
- not on file
- Product code
- IZL
- Firm FEI
- 1000524572
- Firm city
- Bothell
- Firm state
- WA
- 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
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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